MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381211
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that during use the, bd insyte-n¿ autoguard¿ shielded iv catheter pierced the catheter during reinsertion and was unusable.The following information was provided by the initial reporter: "it turns out that the needle pierces the catheter during reinsertion, making it unusable.This has happened many times in the last month.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 30-jun-2022.H6: investigation summary one sample with open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection.From the sample, the needle was observed to be pierced through the catheter tip area.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 assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the inline tip spear vision inspection system.Based on the verbatim, the needle pierced through the catheter occurred ¿during reinsertion¿.The user is recommended to follow the caution on the instruction for use (ifu), which stated: ¿if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert needle into the catheter tubing as damage may occur¿.Therefore, this non-conformance most likely occurred outside of the manufacturing facility.H3 other text : see h10.
Event or Problem Description
It was reported by the customer that during use the, bd insyte-n¿ autoguard¿ shielded iv catheter pierced the catheter during reinsertion and was unusable.The following information was provided by the initial reporter: "it turns out that the needle pierces the catheter during reinsertion, making it unusable.This has happened many times in the last month.".

• Brand Name: BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: 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 ; 8015296192
• MDR Report Key: 14807905
• Report Number: 8041187-2022-00330
• Device Sequence Number: 11925484
• Product Code: FOZ
• UDI-Device Identifier: 30382903812111
• UDI-Public: 30382903812111
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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
• Operator of Device: Other
• Device Model Number: 381211
• Device Catalogue Number: 381211
• Device Lot Number: 1363105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown