MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number	305945
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
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.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe sftygld 1ml w/ndl 27x1/2 rb was damaged, but still operable the following information was provided by the initial reporter: "it was reported a possible loss of fluid during injecting.Verbatim: 2020-09-17: called consumer to assist with voicemail that was received however, consumer did not answer.Attempted to leave vm and halfway through vm message machine disconnected.Will follow up again.Email received 2020-09-15 16:15:41: hello, received voicemail today from customer who wants to know if we offer a syringe where the piston goes all the way into the hub of the syringe to minimize the loss of fluid.So it sounds like he may be experiencing some loss of fluid during injecting.He said material # 305945.Phone number xxx-xxx-xxxx".
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A dhr check was not performed as the lot number is "unknown" for this complaint.
Event or Problem Description
It was reported that syringe sftygld 1ml w/ndl 27x1/2 rb was damaged, but still operable the following information was provided by the initial reporter: "it was reported a possible loss of fluid during injecting.Verbatim: 2020-09-17: called consumer to assist with voicemail that was received however, consumer did not answer.Attempted to leave vm and halfway through vm message machine disconnected.Will follow up again.Email received: 2020-09-15 16:15:4.1 hello, received voicemail today from customer who wants to know if we offer a syringe where the piston goes all the way into the hub of the syringe to minimize the loss of fluid.So it sounds like he may be experiencing some loss of fluid during injecting.He said material # 305945.Phone number xxx-xxx-xxxx".

• Brand Name: SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10653892
• Report Number: 1920898-2020-01383
• Device Sequence Number: 3161707
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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