MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISION GLIDE¿ HYPODERMIC NEEDLE

Catalog Number	305108
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported before use of the bd precision glide¿ hypodermic needle there was an additional needle that was embedded in the packaging.The consumer states ¿the needle comes out of the packaging.¿ there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one photo was received, and there was a double/ second cannula protruding from the shield.One sample was returned.The cannula was bent.There was a double cannula attached, and an epoxy drip over on the hub.The part had been opened and handled, but it's possible that the tip of the cannula was caught by the shield causing the bend in the cannula.Qn view: no notifications were written for this batch, nor for the associated assembly batch.Dhr review: assembly batch 6208810 had 17 visual inspections performed on 1,000 parts with zero defects noted.Eight shield removal force tests were performed on 40 parts with a minimum removal force of 1.3 lbs., a maximum removal force of 3.9 lbs., and an average of 2.7 lbs.The specification limits for shield removal forces is 0.5 - 5.5 lbs.With an average less than or equal to 4.5 lbs.Investigation conclusion: the cannula assembly area on the nip lines has been modified to prevent mis-assembled cannula from accumulating, and possibly causing double cannula.It is still dependent on the operator to continuously monitor the assembly process for assembly issues.

• Brand Name: BD PRECISION GLIDE¿ HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7353463
• Report Number: 1911916-2018-00110
• Device Sequence Number: 19411134
• Product Code: FMI
• UDI-Device Identifier: 00382903051793
• UDI-Public: 00382903051793
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: Other
• Device Catalogue Number: 305108
• Device Lot Number: 6207962
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/01/2018
• 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: Other