MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD AUTOSHIELD DUO SAFETY PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305115
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda on 23 march, 2020.Medwatch report # (b)(4).Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd autoshield¿ duo safety pen needle penetrated through the shield and caused a needlestick injury to the nurse.This occurred during use.The following information was provided by the initial reporter: material no:305115 batch no: 7285614 it was reported that a nurse was stuck with a needle.Verbatim: nurse administered subcutaneous medication and re-capped the needle utilizing the scoop method.The nurse then proceeded to push on the needle cap to firmly secure it to the needle hub and did not realize that the needle had penetrated the cap, which resulted in a needle stick to the nurse.
Additional Manufacturer Narrative
The following fields have been updated with corrections: b.3.Date of event: (b)(6) 2020.G.4.Date received by manufacturer: 2020-09-10.H.6.Investigation: a device history record review was completed for provided material number 305115 and lot number 7285614.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, six recreation photos were submitted for evaluation by our quality team.The customer recreated the symptom with another sample.The photos show a needle going through the plastic shield at about 45 degrees.The reported defect was induced when recapping the needle assembly which should not be done.
Event or Problem Description
It was reported that bd autoshield¿ duo safety pen needle penetrated through the shield and caused a needlestick injury to the nurse.This occurred during use.The following information was provided by the initial reporter: material no:305115 batch no: 7285614.It was reported that a nurse was stuck with a needle.Verbatim: nurse administered subcutaneous medication and re-capped the needle utilizing the scoop method.The nurse then proceeded to push on the needle cap to firmly secure it to the needle hub and did not realize that the needle had penetrated the cap, which resulted in a needle stick to the nurse.

• Brand Name: BD AUTOSHIELD DUO SAFETY PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10564175
• Report Number: 1911916-2020-00881
• Device Sequence Number: 11657110
• Product Code: FMI
• UDI-Device Identifier: 30382903051152
• UDI-Public: 30382903051152
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (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): 10/02/2020

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 305115
• Device Catalogue Number: 305115
• Device Lot Number: 7285614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/02/2020
• 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