MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Packaging Problem (3007)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Bd corporate headquarters in (b)(6) has been listed and the (b)(6) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter fax #: (b)(6).Device manufacture date: unknown.Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: material number and batch number is unknown; reviews could not be performed.Based on limited information available after unsuccessful attempts to obtain - unable to assess the rm documentation.No physical sample was provided by the customer.Capa is not required at this time.

Event Description

It was reported that the unspecified bd catheter experienced damaged packaging where sterility was compromised.The following information was provided by the initial reporter: product in question was already open (the gel was already out of the needle).

• Brand Name: UNSPECIFIED BD CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12490308
• MDR Text Key: 272680418
• Report Number: 2243072-2021-02344
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• 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