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

Catalog Number	305156
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided medical device expiration date: unknown device manufacture date: unknown a sample is not available for evaluation.However, a no sample investigation will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a nurse picked up a bd¿ hypodermic precisionglide¿ needle without safety after it was used and recapped by a physician during procedures.The needle was protruding from the side of the cap and nurse received a dirty needle stick.There was no report or medical interventions provided.
Additional Manufacturer Narrative
Investigation summary: qn review: unable to complete without a batch number.Dhr review: unable to complete without a batch number.Investigation results: one photo was received by bd for investigation.The needle pierced the shield when the shield was replaced after use.Investigation conclusion: possible root cause: user error.Needles should not be re-shielded after use, and if this is not possible, a one handed passive recapping technique should be used.It is stated in two places on the shelf carton ¿do not reshield used needles¿, and ¿do not force the shield onto the needle, as the needle may penetrate the shield causing injury¿.If corrective/preventative action not required, provide rationale: this is a user technique issue.No capa will be issued.

• Brand Name: BD¿ HYPODERMIC PRECISIONGLIDE¿ NEEDLE WITHOUT SAFETY
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7289313
• Report Number: 1911916-2018-00047
• Device Sequence Number: 16485858
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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 Catalogue Number: 305156
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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