MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG

Model Number	323001
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6) usa has been used as a default.(b)(4).Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger difficult to move, difficult/unable to operate (not drawing) and shield does not detach as intended on lot # 9126619.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, plunger difficult to move, difficult/unable to operate (not drawing) and shield does not detach as intended) was captured and addressed.Investigation summary: customer returned a photo of a poly bag of 1/2cc, 12.7mm, 29g bd pet syringes.No samples were returned therefore the complaint could not be confirmed.A review of the device history record was completed for batch# 9252463.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200827666] noted that did not pertain to the complaint.There was one (1) notification [200821592] noted for out of spec sustaining.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos of the syringes/issues in question were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos of the syringes/issues in question were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that vet syringe 0.5ml x 29g x 12.7mm 10 bag plunger was difficult to move and it was unable to properly aspirate.The following information was provided by the initial reporter: material no:323001 batch no: 9126619.It was reported that the consumer is finding the syringes difficult to use as well as the red needle cap difficult to remove.Also, the syringe barrel does not slide very easily inside the syringe when attempting to draw up the doses or administer them.Verbatim: from phone call on 2020-07-30 10:53:53: pet owner reported plungers on syringes very hard to move.Both for drawing up air and also drawing up insulin.Pet owner reported red needle shields hard to remove too.Verbatim from email: our dog was recently diagnosed with diabetes that requires treatment with insulin.We got a supply of u-40 12.7 mm, 0/5ml bd pet syringes.I am finding that they are more difficult to use than other u-40 syringes.The red needle cap is quite difficult to remove and the syringe barrel does not slide very easily inside the syringe when attempting to draw up the doses or administer them.It makes being precise when drawing up the dose, as well as being quick and smooth when administering the dose, more difficult.I went to your website to see if you have a place for comments and could not find anything.The only mode of communication was this email address.
Event or Problem Description
It was reported that vet syringe 0.5ml x 29g x 12.7mm 10 bag plunger was difficult to move and it was unable to properly aspirate.The following information was provided by the initial reporter: material no:323001 batch no: 9126619 it was reported that the consumer is finding the syringes difficult to use as well as the red needle cap difficult to remove.Also, the syringe barrel does not slide very easily inside the syringe when attempting to draw up the doses or administer them.Verbatim: from phone call on 2020-07-30 10:53:53: pet owner reported plungers on syringes very hard to move.Both for drawing up air and also drawing up insulin.Pet ower reported red needle shields hard to remove too.Verbatim from email: our dog was recently diagnosed with diabetes that requires treatment with insulin.We got a supply of u-40 12.7 mm, 0/5ml bd pet syringes.I am finding that they are more difficult to use than other u-40 syringes.The red needle cap is quite difficult to remove and the syringe barrel does not slide very easily inside the syringe when attempting to draw up the doses or administer them.It makes being precise when drawing up the dose, as well as being quick and smooth when administering the dose, more difficult.I went to your website to see if you have a place for comments and could not find anything.The only mode of communication was this email address.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.10.Device available for eval? yes d.10.Returned to manufacturer on: 2020-08-19 h.3.Device returned to manufacturer: yes h.3.Device eval by manufacturer: yes h.6.Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger difficult to move, difficult/unable to operate (not drawing) and shield does not detach as intended on lot # 9126619.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, plunger difficult to move, difficult/unable to operate (not drawing) and shield does not detach as intended) was captured and addressed investigation summary: customer returned (4) 1/2cc, 12.7mm, 29g u40 bd pet syringes in an open poly bag from lot # 9126619.Customer states that they are finding the syringes difficult to use as well as the red needle cap difficult to remove and the syringe barrel does not slide very easily inside the syringe when attempting to draw up the doses or administer them.All returned syringes were tested to determine the shield removal forces (specs: shield removal force for 1/2cc after sterilization: 0.85-5.95 lbs.).Data: shield removal force syringe 1 4.64 lbs.Syringe 2 4.45 lbs.Syringe 3 4.91 lbs.Syringe 4 4.32 lbs.All removal forces fall within specification.All samples were also tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 9252463.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200827666] noted that did not pertain to the complaint.There was one (1) notification [200821592] noted for out of spec sustaining.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.H3 other text : see h.10.

• Brand Name: VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10394508
• Report Number: 1920898-2020-01037
• Device Sequence Number: 2816893
• Product Code: FMF
• UDI-Device Identifier: 00382903230013
• UDI-Public: 00382903230013
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: 323001
• Device Catalogue Number: 323001
• Device Lot Number: 9126619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other