MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB; PISTON SYRINGE

Catalog Number	305500
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe allergy 1ml w/ndl 28x1/2 rb experienced a sterility breach when the shield was missing and stuck an employee when handling the sealed bag containing the device.
Event or Problem Description
It was reported that the syringe allergy 1ml w/ndl 28x1/2 rb experienced a sterility breach when the shield was missing and stuck an employee when handling the sealed bag containing the device.
Additional Manufacturer Narrative
H.6.Investigation summary: customer returned (10) 1cc, 12.7mm, 28g bd allergy syringes in a sealed poly bag from lot # 8099970.Customer states that the tech was stuck by syringe missing shield inside a sealed bag.The returned poly bag was examined and exhibited the shield off in the bag, exposing the cannula, which could cause a needle stick.A review of the device history record was completed for batch #8099970.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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.Based on the above, no capa is required at this time.Possible root cause is likely during the auto packaging operation that the shield could catch on the outside of the carton and when the product tamp station presses the air out of the bags the shield could be removed exposing the cannula.This would likely proceed through the system undetected unless it was detected during hourly visual inspections for missing components.Manufacturing has not taken additional steps for detection of this defect at this time.

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8368207
• Report Number: 1920898-2019-00205
• Device Sequence Number: 2120342
• Product Code: FMF
• UDI-Device Identifier: 00382903055005
• UDI-Public: 00382903055005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 305500
• Device Lot Number: 8099970
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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