MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305145
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 that a hypodermic needle precisionglide¿ without safety had a cannula that was pulled out of hub and released into the patient's skin during use.The cannula was pulled from the patient without incident.
Additional Manufacturer Narrative
Investigation: 269 units were received for evaluation.They were tested for cannula pull force, finding the range between 16 lbs to 19lbs.Per the specification the minimum is 8lbs therefore failure mode is not verified and a root cause of the complaint could not be determined.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that a hypodermic needle precisionglide¿ without safety had a cannula that was pulled out of hub and released into the patient's skin during use.The cannula was pulled from the patient without incident.

• Brand Name: HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY
• 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: 8096363
• Report Number: 1911916-2018-00695
• Device Sequence Number: 16670536
• Product Code: FMI
• UDI-Device Identifier: 30382903051459
• UDI-Public: 30382903051459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/15/2019

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 Expiration Date: 08/31/2022
• Device Catalogue Number: 305145
• Device Lot Number: 7177790
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 02/15/2019
• 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