MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 329917

Device Problem Inaccurate Information (4051)

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

Event Date 06/04/2023

Event Type  malfunction  

Event Description

It was reported while using bd safeassist¿ safety pen needle 30g x 5mm (100 count) the label information was incorrect.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: the customer informed us that the following products are labeled with a wrong pzn: we have subsequently had to establish that the following product is labelled with a wrong pzn: art.329917, correct pzn: 15320182, wrong labelling on the package pzn: 15320176.Delivery no.601328 order no.Psn-155670 40 x 100 bd safeassist 30g sich pen nadeln 8mm pzn: 15320182 art.329917 charge nr.3010167.Delivery no.598484 order no.Psn-155584 40 x 100 bd safeassist 30g sich pen nadeln 8mm pzn: 15320182 art.329917 charge nr.3010167.Delivery no.595766 order no.Psn-155497 restmenge 53 x 100 bd safeassist 30g sich pen nadeln 8mm pzn: 15320182 art.329917 charge nr.3010167.

Manufacturer Narrative

H3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd safeassist¿ safety pen needle 30g x 5mm (100 count) the label information was incorrect.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: the customer informed us that the following products are labeled with a wrong pzn: we have subsequently had to establish that the following product is labelled with a wrong pzn: art.(b)(4), correct pzn: (b)(4), wrong labelling on the package pzn: (b)(4).Delivery no.(b)(4) order no.(b)(4).40 x 100 bd safeassist 30g sich pen nadeln 8mm pzn: (b)(4) art.(b)(4) charge nr.(b)(4).Delivery no.(b)(4) order no.(b)(4).40 x 100 bd safeassist 30g sich pen nadeln 8mm pzn: (b)(4) art.(b)(4) charge nr.(b)(4).Delivery no.(b)(4) order no.(b)(4).Restmenge 53 x 100 bd safeassist 30g sich pen nadeln 8mm pzn: (b)(4) art.(b)(4) charge nr.(b)(4).

Manufacturer Narrative

H6: investigation summary: no samples/photos were returned for investigation.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.This complaint was confirmed to be a packaging graphics error therefore a review of the packaging process at the site is not required.

• Brand Name: BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT)
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17222059
• MDR Text Key: 318339695
• Report Number: 9616656-2023-00664
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 329917
• Device Lot Number: 3010167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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