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

Catalog Number 682245

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for the additional lot number is as follows: medical device lot #: 1357456.Medical device expiration date: 31-dec-2026.Device manufacture date: 23-dec-2021.Medical device lot #: 1323270.Medical device expiration date: 30-nov-2026.Device manufacture date: 19-nov-2021.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

After the catheter was placed, when the cannula was out, the customers noticed that the catheter leaked.Once at the transition to the hard plastic, once in the middle of the catheter.The catheter was immediately removed and a new one had to be placed! the catheters have small holes, it has nothing to do with the closure of the catheter (red part) this works.The catheters themselves are leaking! please exchange 6 ve free of charge.

Event Description

It was reported that during use 21 bd¿ arterial cannula catheters were damaged with holes and leaked.The following information was provided by the initial reporter: after the catheter was placed, when the cannula was out, the customers noticed that the catheter leaked.Once at the transition to the hard plastic, once in the middle of the catheter.The catheter was immediately removed and a new one had to be placed! the catheters have small holes, it has nothing to do with the closure of the catheter (red part) this works.The catheters themselves are leaking! please exchange 6 ve free of charge.

Manufacturer Narrative

The following fields were updated due to additional information: b5: describe event or problem: it was reported that during use 21 bd¿ arterial cannula catheters were damaged with holes and leaked.The following information was provided by the initial reporter: after the catheter was placed, when the cannula was out, the customers noticed that the catheter leaked.Once at the transition to the hard plastic, once in the middle of the catheter.The catheter was immediately removed and a new one had to be placed! the catheters have small holes, it has nothing to do with the closure of the catheter (red part) this works.The catheters themselves are leaking! please exchange 6 ve free of charge.D10: device available for eval: yes.D10: returned to manufacturer on: 09-sep-2022.H6: investigation summary: twenty-one (21) samples were received by our quality team for evaluation.Eighteen (18) unopened unused samples were received from batch 1357456.One used sample was received without batch identification.One unopened unused sample was received from batch 1323270.One open unused sample was received from batch 1323270.The used sample without batch identification was observed to have a hole in the catheter tubing.The hole area is approximately 4 mm from the nose area of the floswitch housing.The opened unused sample from batch 1323270 was observed to have a hole in the catheter tubing.The hole area is approximately 4 mm from the nose area of the floswitch housing.This hole is similar to that of the used sample of the unknown batch.The unopened unused sample from batch 1323270 was visually inspected and then subjected to leakage and aspiration testing.This returned sample passed the inspections.The eighteen unopen unused samples from batch 1357456 were subjected to visual inspection, leakage, and aspiration testing.Ten samples were detected with a hole on the catheter tubing form the catheter nose.The same ten samples also failed the leakage and aspiration testing.The hole on the catheter tubing of the ten samples is approximately 4 mm from the floswitch housing nose, similar to hole observed on the returned used sample opened unused sample from batch 1323270.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.A simulation was carried out by injecting green colored water into the used sample of unknown batch.Leakage was observed from the hole in the catheter tubing that was observed earlier.A corrective and preventive action project has been opened to further investigate this leakage.

• Brand Name: BD¿ ARTERIAL CANNULA
• Type of Device: BD¿ 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: 15136570
• MDR Text Key: 304197668
• Report Number: 8041187-2022-00408
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/23/2022
• 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