MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM HP 100 BOX FR; PEN NEEDLE

Catalog Number 320562

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Pain (1994); Underdose (2542)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that pen ndl 32g 4mm hp 100 box fr needles are defective and unable to fully deliver insulin, leading to hyperglycemia.This was discovered during use.The following information was provided by the initial reporter: user of the bd needles for 23 years, i'd like to inform you this: since the new needles, the injection is often painful.There are defective needles, meaning the insulin does not pass completely and we don't know what dose has been injected, leading to hyperglycemia.

Manufacturer Narrative

H.6.Investigation summary: no samples or photos were returned for analysis.No dhr review can be carried out as lot number is unknown.Based on no sample, the cstomer complaint could not be confirmed.H3 other text : see section h.10.

Event Description

It was reported that pen ndl 32g 4mm hp 100 box fr needles are defective and unable to fully deliver insulin, leading to hyperglycemia.This was discovered during use.The following information was provided by the initial reporter: user of the bd needles for 23 years, i'd like to inform you this: since the new needles, the injection is often painful.There are defective needles, meaning the insulin does not pass completely and we don't know what dose has been injected, leading to hyperglycemia.

• Brand Name: PEN NDL 32G 4MM HP 100 BOX FR
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9123763
• MDR Text Key: 163974589
• Report Number: 9616656-2019-00912
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 10/08/2019

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: Lay User/Patient
• Device Catalogue Number: 320562
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other