MAUDE Adverse Event Report: BD CARIBE LTD. BD 405138 WHITACRE HIGH-FLOW PENCIL POINT SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405138

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported that the bd 405138 whitacre high-flow pencil point spinal needle experienced packaging damage where sterility was compromised.The following information was provided by the initial reporter: wrapping paper of product is torn.

Manufacturer Narrative

Initial reporter addr 1: (b)(6).Based on the sample provided to bd for evaluation, the reported condition was verified.The probable root cause is an operator error during the manual load step.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging.

• Brand Name: BD 405138 WHITACRE HIGH-FLOW PENCIL POINT SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14946558
• MDR Text Key: 297909021
• Report Number: 2618282-2022-00032
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904051389
• UDI-Public: 00382904051389
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405138
• Device Lot Number: 1096412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1