MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 393202

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter broke off in a vein during use, and needed to be removed from the vein through surgery.

Manufacturer Narrative

Results: 3 photos were returned for investigation of this complaint: the first photo shows 1 used vp with shorter catheter tubing (broken catheter).The second photo shows 1 used vp with broken catheter and unknown object on the table.The third photo shows 1 used vp with several surgical tools and scissors.From the photos, the catheter appears to be cut by sharp object.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: the root cause cannot be established as there is no process in the manufacturing facilities that could have caused this nonconformance.A broken catheter will automatically be rejected by an automated vision inspection machine as the lie distance will be out of specification.Therefore, this reported nonconformance could have occurred out of the manufacturing facilities.The manufacturing process was reviewed.There is no process in the manufacturing facilities that could have caused this nonconformance.The manufacturing process includes an automated vision inspection machine that will reject parts not meeting lie distance requirement.A broken catheter will automatically be rejected as the lie distance will be out of specification.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7060405
• MDR Text Key: 92964794
• Report Number: 8041187-2017-00223
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 393202
• Device Lot Number: 7018299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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): Required Intervention