MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM HP 100 BOX 1200 US; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 320550

Device Problems Leak/Splash (1354); Misconnection (1399); Failure to Deliver (2338)

Patient Problems Irritation (1941); Skin Inflammation/ Irritation (4545)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

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 an unspecified number of pen ndl 32g 4mm hp 100 box 1200 us had insufficient cannlua length, leakage, and were difficult to operate during use.The following was reported by the initial reporter: "it was reported that pen needles are much shorter and are leaving welts at injection site.Also reported pen needles leak so she doesn't know if she's getting her full dose.Verbatim: consumer reported the pen needles are much shorter and leaving welts at her injection sites.Stated the pen needles also leak so she doesn't know if she is getting her full medication dose.Stated she doesn't like the bd nano 2nd gen and they do not work.Lot # 0077818, cat # 320550.Date of event: (b)(6).Samples: yes, sending mail kit".

Event Description

It was reported that an unspecified number of pen ndl 32g 4mm hp 100 box 1200 us had insufficient cannlua length, leakage, and were difficult to operate during use.The following was reported by the initial reporter: "it was reported that pen needles are much shorter and are leaving welts at injection site.Also reported pen needles leak so she doesn't know if she's getting her full dose.Verbatim: consumer reported the pen needles are much shorter and leaving welts at her injection sites.Stated the pen needles also leak so she doesn't know if she is getting her full medication dose.Stated she doesn't like the bd nano 2nd gen and they do not work.Lot # 0077818; cat # 320550; date of event: (b)(6) 2020 - (b)(6) 2020; samples: yes, sending mail kit.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.H3 other text : see h.10.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/9/2021.H.6.Investigation: customer returned (34) sealed 32gx4mm bd pen needles from lot# 0077818.The customer reported that pen needles are much shorter, are leaving welts at injection site, leak and do not work.30 out of the 34 returned pen needles were examined, then tested for visual inspection of point geometry, outer diameter and lube coverage, cannula length, and flow using a test pen injector.All observations measured within specification and no defects were observed.All 30 tested samples were able to attach to the pen, expel, and detach from the pen properly.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.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that an unspecified number of pen ndl 32g 4mm hp 100 box 1200 us had insufficient cannlua length, leakage, and were difficult to operate during use.The following was reported by the initial reporter: "it was reported that pen needles are much shorter and are leaving welts at injection site.Also reported pen needles leak so she doesn't know if she's getting her full dose.Verbatim: consumer reported the pen needles are much shorter and leaving welts at her injection sites.Stated the pen needles also leak so she doesn't know if she is getting her full medication dose.Stated she doesn't like the bd nano 2nd gen and they do not work.Lot # 0077818, cat # 320550, date of event: 12/ 12/20-12/16/20.Samples: yes, sending mail kit".

• Brand Name: PEN NDL 32G 4MM HP 100 BOX 1200 US
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 11159503
• MDR Text Key: 232375132
• Report Number: 9616656-2021-00015
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• PMA/PMN Number: K182320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 0077818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1