MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE, SUB-Q

Catalog Number	305115
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Investigation: a sample was not available for evaluation by the manufacturing plant.A quality engineer could not perform an investigation into the reported issue.The reported issue could not be verified and a possible root cause could not be determined since there was no sample available for evaluation.A device history record was performed on the reported batch and found zero defects regarding broken or bent needles.There were no notifications written during production of this batch.Qn review: no notifications were written for this batch, nor for the associated assembly batch.Dhr review: assembly batch 7086591 had 11 visual inspections performed on (b)(4) parts with one defect noted for low lube solids.The issue was caught at the beginning of the batch, and no product was affected.Investigation results: unable to perform as no photos or samples were provided.Possible root cause: unable to determine as no photos or samples were provided.If corrective/preventative action not required, provide rationale: no capa will be issued as the defect could not be confirmed.
Event or Problem Description
It was reported that after a patient¿s sub-q injection, the needle of a bd precisionglide¿ needle, sub-q bent and broke off.This caused the user to receive a dirty needle stick.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE, SUB-Q
• Common Device Name: NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7355420
• Report Number: 1911916-2018-00086
• Device Sequence Number: 18977936
• Product Code: FMI
• UDI-Device Identifier: 30382903051152
• UDI-Public: 30382903051152
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: Nurse
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 305115
• Device Lot Number: 7086749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/20/2018
• 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: Required Intervention