MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE INTEGRA 25X1 RB TW; PISTON SYRINGE

Model Number	305311
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 needle integra 25x1 rb tw was not sterile.The following information was provided by the initial reporter: "it was reported that a needle stick injury occurred after a needle was not capped within packaging.Verbatim - per customer: i wanted to alert you to an issue with our integra needles.We had no separate boxes, one with 1 inch and one with 5/8inch replacement needles.They were out of the safety cap and someone here got stuck with it.I wrote down the lot number for you.I did check everything in the draws and went through boxes and put safety checks on the boxes i went through but i wanted to alert you to this.I have the needles and i can send you a picture.(b)(6) rep stated that needle was not capped in package and was sticking out through wrapper.".
Event or Problem Description
It was reported that needle integra 25x1 rb tw was not sterile.The following information was provided by the initial reporter: "it was reported that a needle stick injury occurred after a needle was not capped within packaging.Verbatim - per customer: i wanted to alert you to an issue with our integra needles.We had no separate boxes, one with 1 inch and one with 5/8inch replacement needles.They were out of the safety cap and someone here got stuck with it.I wrote down the lot number for you.I did check everything in the draws and went through boxes and put safety checks on the boxes i went through but i wanted to alert you to this.I have the needles and i can send you a picture.Mckesson rep stated that needle was not capped in package and was sticking out through wrapper.".
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was performed for provided lot number 6299679.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, 2 physical and 1 picture sample was received for evaluation by our quality team.Through examination of the sample, both have the plastic shield that is not assembled to the needle hub leaving the needle unprotected.One of the samples has part of the needle out of the bottom packaging blister.The photo shows the samples received.The cause for this defect could have resulted during the packaging process where a jam may have occurred, causing the plastic shield to become disassembled from the rest of the part.The web was sealed over, leaving the components inside, going undetected in the next process.Further action has not been determined necessary at this time.

• Brand Name: NEEDLE INTEGRA 25X1 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10751997
• Report Number: 1911916-2020-00981
• Device Sequence Number: 3645851
• Product Code: MEG
• UDI-Device Identifier: 30382903053118
• UDI-Public: 30382903053118
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• 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): 11/06/2020

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 Expiration Date: 10/31/2021
• Device Model Number: 305311
• Device Catalogue Number: 305311
• Device Lot Number: 6299679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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