MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 381212

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

The customer provided four potential lot numbers for this incident. The information for each lot number is as follows: medical device lot #: 6141428, medical device expiration date: 5/31/2021, device manufacture date: 5/20/2016. Medical device lot #: 6053154, medical device expiration date: 2/28/2021, device manufacture date: 2/22/2016. Medical device lot #: 5354408, medical device expiration date: 12/31/2020, device manufacture date: 12/20/2015. Medical device lot #: 6113190, medical device expiration date: 4/30/2021, device manufacture date: 4/22/2016. Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).

Event Description

It was reported that a 24 g x. 75 in bd insyte¿ peripheral iv catheter broke off at the hub while it was being removed from a patient (a dog). The dog received several x-rays and it appears that the catheter is stuck in the dog's vein. No additional information was provided.

Manufacturer Narrative

Results: six unused samples in sealed packages were returned for evaluation. A visual inspection of all units revealed no abnormalities. A review of the device history records for the potential lot numbers 6141428, 6053154, 5354408, and 6113190 revealed no irregularities during the manufacturing process. A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue. Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER
• Type of Device: INTRAVASCULAR 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: 6535785
• MDR Text Key: 74145546
• Report Number: 8041187-2017-00040
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/01/2017 Patient Sequence Number: 1