MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD¿ BLUNT FILL NEEDLE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 305180

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an expiration date issue occurred before use with bd¿ blunt fill needles.The following information was provided by the initial reporter, "could you kindly help me to cross check on the expiry date for the po# (b)(4).Expiry date in packing slip ¿ 02/29/2024, expiry date in box ¿ 2024 / 01/31.".

Manufacturer Narrative

Investigation: no samples or photos received for investigation.The batch was created in dec-2018 which would have an expiration date of 2024-01-31.The date on the packaging slip is manually entered by associates prior to shipment.The expiration date was incorrectly entered when completing the packing slip.Based on the information provided by the customer the packing slip has the incorrect expiration date.However, the boxes have the correct expiration date printed, therefore, no corrective or preventative action will be taken.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that an expiration date issue occurred before use with bd¿ blunt fill needles.The following information was provided by the initial reporter, "could you kindly help me to cross check on the expiry date for the (b)(4).Expiry date in packing slip ¿ 02/29/2024; expiry date in box ¿ 2024 / 01/31.".

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8898999
• MDR Text Key: 159415410
• Report Number: 1911916-2019-00814
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903051800
• UDI-Public: 30382903051800
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

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
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 305180
• Device Lot Number: 8361943
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2018
• 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
• Patient Outcome(s): Other