MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ ARTERIAL CANNULA

Catalog Number 682245

Device Problem Defective Device (2588)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported that during use, the bd¿ arterial cannula had flow switch that did not work.The following information was provided by the initial reporter, translated from swedish to english: after placing the arterial cannula, when pulling out the needle, the red on/off button didn´t work.

Manufacturer Narrative

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

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-dec-2022.H6: investigation summary: one sample was receive by our quality team for evaluation.A simulation was conducted by pumping green colored water into the returned sample.Leakage was observed at the floswitch button area.The sample was visually observed to have "hole liked" damage on the silicone tube.The floswitch button and steel ball was removed, and a hole was observed in the middle of the silicone tube and a damage on the edge facing the guide bush end.The leakage could have come from the damage and hole observed.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The arterial cannula assembly needle line was reviewed.The silicone tube is inserted by a pre-silicone valve insert probe during assembly.If there was foreign matter on the tip of the insert probe, it can cause the silicone valve to be damaged during insertion.There is a shift start-up cleaning performed, if this cleaning is not done properly, there could be foreign matter residue on the probe.Current quality controls include an in-process leakage and aspiration inspection and an outgoing leakage and aspiration inspection.The manufacturing setup specifications will be updated to include instructions on the inspection of the probe tip after cleaning.

Event Description

It was reported that during use, the bd¿ arterial cannula had flow switch that did not work.The following information was provided by the initial reporter, translated from swedish to english: after placing the arterial cannula, when pulling out the needle, the red on/off button didn´t work.

• Brand Name: BD¿ ARTERIAL CANNULA
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15535257
• MDR Text Key: 306616275
• Report Number: 8041187-2022-00569
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: 1357512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2022
• 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