MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 382534

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the catheter broke/separated from the hub.The following information was provided by the initial reporter.The customer stated: "on removal of an arterial line in icu on (b)(6) 2021, it was identified the tip of the arterial line was not intact.The tip was surgically removed and the tip preserved.".

Event Description

It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the catheter broke/separated from the hub.The following information was provided by the initial reporter.The customer stated: "on removal of an arterial line in icu on (b)(6) 2021, it was identified the tip of the arterial line was not intact.The tip was surgically removed and the tip preserved.".

Manufacturer Narrative

The investigation found that the returned sample was not a 20g x 1.16in.Catheter.Measurements suggested the catheter could be from a 20g x 1.88in.Unit.This supplemental is to capture the unknown material number for the returned sample.H.6.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one used insyte autoguard catheter tubing with no product documentation or packaging.A gross visual inspection of the returned sample found that the catheter tubing length was larger than the length of the reported product.The reported material number was for a 20g x 1.16in.Catheter.A measurement with a ruler found that the returned catheter tubing measured 1.80 inches, indicating that the catheter was likely a 20g x 1.88in.Unit as that is the only larger size available for a 20g unit.The total length of the catheter tubing for a 20g x 1.88in.Unit, including the material inside the nose of the adapter, is larger than 1.88 inches.As the returned sample was only 1.80 inches in length, it was concluded that the returned sample was missing some material.Microscopic inspection found that the missing end of the catheter tubing had an angled shape.The surface with the missing end was mostly a smooth surface with sections of rough surface near the outer diameter.This indicated that the catheter was likely partially cut by a sharp instrument, creating the smooth surface, and then experienced tensile stress that broke the catheter tubing, causing the rough surface.Based on appearance and shape of the cut, the most likely root cause was determined to be coming into contact with a sharp instrument (e.G., scissors) during use.Scissors or other sharp instruments may damage the catheter if used at or near the insertion site.It is also possible the damage could have occurred due to the needle piercing through the catheter during venipunture; however, the characteristic v-shaped cut was not present.Also, it is unlikely that the torn edge of the tubing would look smooth and uniform if the flexible tubing material was bent, stretched, and pulled over time.A device history record review could not be performed as the lot number is unknown.H3 other text : see h.10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12830602
• MDR Text Key: 280947649
• Report Number: 1710034-2021-00992
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825340
• UDI-Public: 30382903825340
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110443
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382534
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 01/13/2022
• 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
• Patient Outcome(s): Other