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

Catalog Number 305540

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/31/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11776754
• MDR Text Key: 249074897
• Report Number: 1920898-2021-00520
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: 00382903055401
• Combination Product (y/n): N
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305540
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1