MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32GA 4MM 14BAG 700CASE JP; PEN NEEDLE

Catalog Number 320136

Device Problems Break (1069); Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that pen ndl 32 ga 4 mm 14 bag 700 case jp cannula broke off and was unable to deliver medication.This occurred on 2 occasions before use.The following information was provided by the initial reporter: the customer reported that the drug had not come out.

Manufacturer Narrative

H6: investigation summary four open 32g x 4mm pen needle samples and five photos were returned from lot.No.0098157, cat.No.320136.Visual examination was carried out on the returned samples and photos and a bent patient end of cannula was observed on one sample and a broken patient end of cannula was observed on the remaining three samples.No manufacturing related issues were observed on the samples.Due to the condition the samples were returned no clog testing could be carried out.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.

Event Description

It was reported that pen ndl 32ga 4mm 14bag 700case jp cannula broke off and was unable to deliver medication.This occurred on 2 occasions before use.The following information was provided by the initial reporter: the customer reported that the drug had not come out.

• Brand Name: PEN NDL 32GA 4MM 14BAG 700CASE JP
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10611041
• MDR Text Key: 209584959
• Report Number: 9616656-2020-00983
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320136
• Device Lot Number: 0022827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other