MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA WITH BD FLOWSWITCH¿; WIRE GUIDED CATHETER

Catalog Number 682245

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6)."there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7048114; medical device expiration date: 02-28-2022; device manufacture date: 04/06/2017.Medical device lot #: 6295123; medical device expiration date: 10-31-2021; device manufacture date: 11/23/2016; medical device lot #: 7138033; medical device expiration date: 05-31-022; device manufacture date: 06/13/2017.Medical device lot #: 7199165; medical device expiration date: 07-31-2022; device manufacture date: 08/24/2017.Medical device lot #: 7138046; medical device expiration date: 05-31-2022; device manufacture date: 07/13/2017.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 preoperative application of the arterial cannula into the right radial artery for hemodynamic monitoring with increased cardiac risk was easy and occurred with one stitch, i.E.The needle was pulled immediately after the stitch from the cannula and no longer pushed forward into the cannula,.When pushing the cannula forward no resistance was felt.After monitoring the patient in the recovery room, ie about 5 hours after placing the cannula, it was pulled out at about 13:15, leaving a 3.5 cm long piece in the body." found during use.No other actions or medical intervention noted.

Manufacturer Narrative

Two actual samples were returned for investigation.Our quality engineer inspected the returned units visually and microscopically, and confirmed the reported observation of a broken catheter on one of the samples.The manufacturing process was reviewed and there is no process in the manufacturing facilities that could have caused this nonconformance.There is an automated vision inspection machine at the arterial cannula assembly machine to check and auto reject parts not meeting the lie distance requirement.A broken catheter would automatically be rejected as the lie distance would be out of specification.A device history record review showed no non-conformances associated with this issue during the production of this batch.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD ARTERIAL CANNULA WITH BD FLOWSWITCH¿
• Type of Device: WIRE GUIDED 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: 7437435
• MDR Text Key: 105920499
• Report Number: 8041187-2018-00116
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: SEE H.10.
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other