MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ 27 G X 1-1/4" HYPODERMIC NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305136
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported the needle broke during use.To aid in the investigation, one sample with the plastic shield, but no packaging blister, and one photo was received for evaluation by our quality team.The needle is broken with the bottom part of the needle attached to the needle hub.A visual inspection was performed with a 30x microscope.The area where the needle is broken shows damage similar to the needle being twisted.No other defects or imperfections were observed.The two photos provided show the sample received.A device history record review was completed for provided material number 305136, lot number 1238482.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the manufacturing process was completed looking for a possible area where the condition shown could have been induced and no findings were observed.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed, but a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd precisionglide¿ 27 g x 1-1/4" hypodermic needles needle broke.The following information was provided by the initial reporter: we were notified of a complaint from a customer stating needle broke during use.

• Brand Name: BD PRECISIONGLIDE¿ 27 G X 1-1/4" HYPODERMIC NEEDLES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15164112
• Report Number: 1911916-2022-00388
• Device Sequence Number: 5732424
• Product Code: FMI
• UDI-Device Identifier: 00382903051366
• UDI-Public: 00382903051366
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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 Catalogue Number: 305136
• Device Lot Number: 1238482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown