MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH NEEDLE; PISTON SYRINGE

Model Number	928852
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ insulin syringe with needle hub separated into the shield.This occurred on 5 occasions during use.The following information was provided by the initial reporter: material no.928852 batch no.8064780.It was reported that needle shield is hard to removed and 1 needle hub separated into the shield.Verbatim: issue: consumer reported needle shield is hard to remove.1 needle came off remained in the needle shield.He uses the 3/10cc, 29g, 12.7 needle.Consumer uses new needle for his injection.
Additional Manufacturer Narrative
H.6.Investigation summary customer returned six (6) loose 29gx12.7mm, 0.3ml bd insulin syringes, and open polybags from lot 8064780.Consumer reported needle shield is hard to remove; 1 needle came off remained in the needle shield.All six returned syringes were examined, and it was observed that one of the syringes exhibited needle-hub/shield separation; no damage to the barrel tip was observed.The other five syringes were tested to determine the shield removal force (specs: shield removal force for 0.3 ml syringe after sterilization is 0.85 to 5.95lbs) and the following was observed: sample number shield removal force (lbs) sample 1 3.84, sample 2 4.58, sample 3 3.06, sample 4 3.35 and sample 5 3.50.All five of the tested syringes tested within specification.Manufacturing will be notified of the needle-hub separation issue.A review of the device history record was completed for batch# 8064780.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion bd was able to duplicate or confirm the customer¿s indicated failure (needle hub separates).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: l2l dispatch #18413 was for raised hubs.The amplifier was out of adjustment.Corrective action: the amplifier was adjusted.Rationale tip-2019-37 was implemented on 10jul2019 for increased sampling for needle hub separates in 0.3ml.Capa1122103 has been opened to address this issue of hub separates.
Event or Problem Description
It was reported that bd¿ insulin syringe with needle hub separated into the shield.This occurred on 5 occasions during use.The following information was provided by the initial reporter: material no.928852, batch no.8064780.It was reported that needle shield is hard to removed and 1 needle hub separated into the shield.Issue: consumer reported needle shield is hard to remove.1 needle came off remained in the needle shield.He uses the 3/10cc, 29g, 12.7 needle.Consumer uses new needle for his injection.

• Brand Name: BD INSULIN SYRINGE WITH NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9534201
• Report Number: 1920898-2019-01485
• Device Sequence Number: 2837283
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• 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): 01/15/2020

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: 03/31/2023
• Device Model Number: 928852
• Device Catalogue Number: 928852
• Device Lot Number: 8064780
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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