MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE 18 G; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number 305180

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported the sanitary registration print on packaging is not legible.To aid in the investigation, four photos were provided for evaluation by our quality team.The first photo shows sealed packaging blisters from the top web side.The second photo shows the packaging blisters from the top web side.The third photo shows the top web printing from the bottom side where the batch number and expiration date are located.The fourth photo shows printing on the bottom web with the register number information.The printing looks permanent, but the resolution could be better.It could be possible the product received the registration number when they were imported and before the distribution to the customer.A device history record review was completed for provided material number: 305180, lot number: 8173880.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.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 Description

It was reported while using bd¿ blunt fill needle 18 g 600 pieces had illegible print.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: the sanitary registration print in packaging is not legible.(b)(4) units affected by the issue.After doing an internal evaluation, customer has decided to use products although the issue.

• Brand Name: BD¿ BLUNT FILL NEEDLE 18 G
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• 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: 15985703
• MDR Text Key: 308194531
• Report Number: 1911916-2022-00740
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903051800
• UDI-Public: (01)30382903051800
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 305180
• Device Catalogue Number: 305180
• Device Lot Number: 8173880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• 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