MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER WITH WINGS 22 G X 1.00 IN; INTRAVASCULAR CATHETER

Model Number 381323

Device Problem Material Perforation (2205)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

Patient¿s birthday was not provided, (b)(6) 2015 was used based on age of patient.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte-w¿ iv catheter with wings 22 g x 1.00 in the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: i had a problem today, (b)(6) 2023, during a peripheral catheter placement in the pediatric emergency room, on an 8 year old patient.Several catheters were defective, slightly pierced.

Manufacturer Narrative

H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h10.

Event Description

It was reported while using bd insyte-w¿ iv catheter with wings 22 g x 1.00 in the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: i had a problem today, (b)(6) 2023, during a peripheral catheter placement in the pediatric emergency room, on an 8 year old patient.Several catheters were defective, slightly pierced.

• Brand Name: BD INSYTE-W¿ IV CATHETER WITH WINGS 22 G X 1.00 IN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16933966
• MDR Text Key: 315489282
• Report Number: 8041187-2023-00214
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: (01)30382903813231
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151698
• 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: 05/25/2023

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 Model Number: 381323
• Device Catalogue Number: 381323
• Device Lot Number: 2275987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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
• Patient Age: 8 YR