MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD 20G X 1.77IN (1.1 X 45 MM) ARTERIAL CANNULA WITH FLOWSWITCH

Catalog Number 682245

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

The exact lot number involved in this incident is unknown.The customer provided the following three potential lot numbers that were found in the facility: lot 5348403, medical device expiration date 12/31/2020, device manufacture date 12/14/2015; lot 6074059, medical device expiration date 03/31/2021, device manufacture date 03/14/2016; lot 6138030, medical device expiration date 05/31/2021, device manufacture date 05/17/2016.(b)(4).(b)(6).

Event Description

It was reported that when the suspect device was removed, the catheter broke off and was retained in the patient's artery.The broken catheter was removed surgically.

Manufacturer Narrative

Device evaluation: result - one used sample was returned for investigation.A broken catheter was observed on the returned sample.The broken catheter appears to have possibly been cut by a sharp object.The manufacturing process was reviewed and there is no process in the manufacturing facility that could have caused this nonconformance.The manufacturing process includes an automated vision inspection machine that will reject parts not meeting lie distance requirements.A broken catheter will automatically be rejected as the lie distance will be out of specification.Therefore, this nonconformance could have occurred out of the manufacturing facilities.A review of the device history was reviewed for the potential reported lot numbers 5348403, 6138030 and 6074059.No quality notification was raised for similar nonconformance during the production of these batches.Conclusion - bd was able to confirm the customer's indicated failure mode as a broken catheter was observed on the returned sample.An absolute root cause for this incident cannot be determined.

• Brand Name: BD 20G X 1.77IN (1.1 X 45 MM) ARTERIAL CANNULA WITH FLOWSWITCH
• Type of Device: ARTERIAL CANNULA
• 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: 6231858
• MDR Text Key: 64131935
• Report Number: 8041187-2017-00001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K850349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention