MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: level a 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 foreign matter in syringe on lot # 9133772.Investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 9133772.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200827888, 200824222] noted that did not pertain to the complaint.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 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 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 syringe 0.5ml 31ga 8mm 10bag 500 pl/wg had a clear liquid in it.This was discovered during use.The following information was provided by the initial reporter: material no.: 928857 batch no.: 9133772.It was reported that a clear liquid was seen when the plunger is pushed up.Verbatim: pharmacist called on behalf of consumer.Stated, consumer is seeing a clear liquid when plunger is pushed up.Stated, when consumer found this issue, he bought box back to store for replacement.Pharmacist was able to duplicate issue but stated, he does not see it with every syringe.Syringes found with "clear liquid" were not used.
Event or Problem Description
It was reported that syringe 0.5ml 31ga 8mm 10bag 500 pl/wg had a clear liquid in it.This was discovered during use.The following information was provided by the initial reporter: material no.: 928857 batch no.: 9133772.It was reported that a clear liquid was seen when the plunger is pushed up.Verbatim: pharmacist called on behalf of consumer.Stated, consumer is seeing a clear liquid when plunger is pushed up.Stated, when consumer found this issue, he bought box back to store for replacement.Pharmacist was able to duplicate issue but stated, he does not see it with every syringe.Syringes found with "clear liquid" were not used.
Additional Manufacturer Narrative
H.6.Investigation summary: level a 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 foreign matter in syringe on lot # 9133772.Investigation summary: customer returned (17) 1/2cc, 8mm, 31g walgreens syringes (7 in an open poly bag, 10 in a sealed poly bag) from lot # 9133772.Customer states that they are seeing a clear liquid when the plunger is pushed up.All returned syringes were examined and no foreign matter was observed in any of the samples.All samples were also tested and 2 out of 7 samples from the open poly bag and 2 out of 10 samples from the sealed poly bag exhibited a clear droplet of material come out of the cannula when the plunger rod was fully depressed.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.Manufacturing (holdrege) will be notified of this issue.A review of the device history record was completed for batch# 9133772.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200827888, 200824222] noted that did not pertain to the complaint.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: - confirmed: bd was 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: as per investigation completed by manufacturing under investigation child (b)(4).On 20 feb 2020, holdrege received photos of a complaint for fm in syringe.Visual inspection of the picture shows a liquid on the cannula of a syringe.Process summary: automatic syringe assembly machine, which feeds 1/2cc, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Root cause: air bubbles in the silicone guns.Corrective action: l2l dispatch #69320 was created to adjust the silicone gun.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9662467
• Report Number: 1920898-2020-00070
• Device Sequence Number: 11425643
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 9133772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/24/2020
• 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