MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320559

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no samples or photos were returned for analysis.No dhr review can be carried out as lot number is unknown.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.

Event Description

It was reported that the non-patient end was bent while attaching the pen ndl 32g 4mm pro 14 bag 700 case jpx to the pen, and the patient couldn't inject medication during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the needle npe was bent when attaching to the pen and the patient couldn't inject.".

• Brand Name: PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9535781
• MDR Text Key: 193695607
• Report Number: 9616656-2019-01286
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other