MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ I; INTRAVASCULAR CATHETER

Catalog Number 391591

Device Problem Packaging Problem (3007)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd venflon¿ i contained foreign matter.The following information was provided by the initial reporter: "there was a hair piece inside a venflon-i pack".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-17.Investigation summary: one sample and four photographs were received from the customer and were used for investigation of the reported defects.The investigation team also used retention samples of material code 391591 and lot number 1162920 for investigating the reported defect.A quality engineer was able to review the returned sample of (1) venflon i 22ga from lot # 1162920 product # 391591 with the reported issue that ¿there was a piece of hair inside a venflon-i pack¿.The dhr of material number 391591 and lot number 1162920 was checked and no quality notification was recorded on this lot.None of the ten retention samples showed hair in them.The investigation on the received sample confirmed the defect reported by the customer.The probable root cause could be that the associate has violated the gmp practices during the production of this lot in the clean room.Bd bawal has very strict and robust gmp guidelines that are followed and adhered to and strictly monitored.The hair could have fallen if the associate has removed the hair net(cap) inside the clean room while he was working near the assembly and packaging machine.It is a human error and we have done a training for all the associates on the gmp practices as an outcome of what happens if the gmp is not practiced inside the clean room.The investigation on the received sample confirmed the defect reported by the customer.H3 other text : see h10.

Event Description

It was reported that bd venflon¿ i contained foreign matter.The following information was provided by the initial reporter: "there was a hair piece inside a venflon-i pack".

• Brand Name: BD VENFLON¿ I
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12639626
• MDR Text Key: 276674581
• Report Number: 2243072-2021-02513
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391591
• Device Lot Number: 1162920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• 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