MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II INSULIN SYRINGE; PISTON SYRINGE

Catalog Number	329406
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that it was difficult to move the bd ultra-fine ii¿ insulin syringe plunger while delivering insulin.This was discovered during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.329406, batch no.Unknown.It was reported that it is difficult to depress the plunger while delivering insulin.Comments: i have been using your product no.329406 for last five years.Lately it has been very difficult to press the plunger while delivering the insulin.I was able to do it with one hand.Now it takes both hands and that also with some difficulty.Something is changed.Either the inside dia.Is too tight or the thickness of the plunger is on high side.It looks a tolerance problem.Pl.Check.The bar code on one of the bags is (b)(4).
Event or Problem Description
It was reported that it was difficult to move the bd ultra-fine ii¿ insulin syringe plunger while delivering insulin.This was discovered during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.329406 batch no.Unknown it was reported that it is difficult to depress the plunger while delivering insulin.Comments: i have been using your product no.329406 for last five years.Lately it has been very difficult to press the plunger while delivering the insulin.I was able to do it with one hand.Now it takes both hands and that also with some difficulty.Something is changed.Either the inside dia.Is too tight or the thickness of the plunger is on high side.It looks a tolerance problem.Pl.Check.The bar code on one of the bags is 08290940601.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check due to unknown lot number.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.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD ULTRA-FINE II INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8776134
• Report Number: 1920898-2019-00636
• Device Sequence Number: 1889816
• Product Code: FMF
• UDI-Device Identifier: 00382903294060
• UDI-Public: 00382903294060
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• 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): 07/16/2019

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 Catalogue Number: 329406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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