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

Catalog Number	305540
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7116549, medical device expiration date: 2022-05-31, device manufacture date: 2017-04-26, medical device lot #: 7116548, medical device expiration date: 2022-05-31.Device manufacture date: 2017-04-26.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 syringe allergy 1ml w/ndl 27x1/2 rb needle was sticking outside the package.The following information was provided by the initial reporter: material no: 305540 batch no: 7116549, 7116548.It was reported the needle was bent outside of the cap / needle sticking outside the package.Verbatim: per update from the customer on 04/09/2021.On 3/31/21 our medical assistant sustained a clean needle stick injury while trying to remove the needle cap, after taking it out of the package tray.The needle was bent at ~160 degree angle and sticking through the cap and she did not see this until the needle punctured her skin.
Additional Manufacturer Narrative
A photo was received by bd for evaluation.A quality engineer was able to review the photo of a 1cc allergy syringe from lot # 7116549, regarding item # 305540 with the reported issue that ¿needle was bent outside of the cap / needle sticking outside the package¿.The photos were examined and exhibited the cannula through the shield, exposing the cannula, which could result in a needle stick.A review of the device history record was completed for batch #7116549 and #7116548.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause could not be determined.
Event or Problem Description
It was reported that syringe allergy 1ml w/ndl 27x1/2 rb needle was sticking outside the package.The following information was provided by the initial reporter: material no: 305540 batch no: 7116549, 7116548.It was reported the needle was bent outside of the cap / needle sticking outside the package.Verbatim: per update from the customer on (b)(6) 2021.On (b)(6) 2021 our medical assistant sustained a clean needle stick injury while trying to remove the needle cap, after taking it out of the package tray.The needle was bent at 160 degree angle and sticking through the cap and she did not see this until the needle punctured her skin.

• Brand Name: SYRINGE ALLERGY 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: 11776754
• Report Number: 1920898-2021-00520
• Device Sequence Number: 19833062
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: 00382903055401
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/06/2021

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 Catalogue Number: 305540
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1