MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE GRAY 16GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381254
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte gray 16ga x 1.16in catheter defective / damaged catheter #16 was requested to the patient, the catheter was uncovered and there was evidence of a fissure in the distal mandrel.Additional information received on december 12, 2024.Could you please share the photo sample of the reported event? the reporting team did not provide a sample or photographic record for evaluation.Could you please share the number of quantities affected? 1 unit.Date of the event? 01/10/2024.Is the sample related to this incident available for analysis? no.For sample collection, please report n/a.Quantity (b)(4).Contaminated sample, if yes please report substance n/a.
Additional Manufacturer Narrative
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.
Event or Problem Description
Catheter #16 was requested to the patient, the catheter was uncovered and there was evidence of a fissure in the distal mandrel.Additional information received on december 12, 2024.Could you please share the photo sample of the reported event? the reporting team did not provide a sample or photographic record for evaluation.Could you please share the number of quantities affected? (b)(4).Unit date of the event? 01/10/2024.Is the sample related to this incident available for analysis? no.For sample collection, please report n/a.Quantity (b)(4).Contaminated sample, if yes please report substance n/a.

• Brand Name: BD INSYTE GRAY 16GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21069441
• Report Number: 2243072-2024-01284
• Device Sequence Number: 8409072
• Product Code: FOZ
• UDI-Device Identifier: 00382903812547
• UDI-Public: (01)00382903812547(11)220902(17)270831(10)2234343
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381254
• Device Lot Number: 2234343
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown