MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number F318108PT

Device Problems Retraction Problem (1536); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reer0591 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "customer was placing powerglide.When she removed the powerglide, the guidewire was coiled and the catheter was sheared.A piece of the catheter remained in the patient's tissue.They confirmed it was not in the patient's vein." additional information received 10/27/2020: ¿i inserted the needle, bevel up, into the skin.Visualized the needle inside the vein, obtained blood flash in the chamber, and deployed the guide wire.It made a clicking sound when it reached the bottom of the device.I then tried to deploy the cathlon and it wouldn't advance.I tried once more, and again it wouldn advance.I then attempted to remove the entire device.The guide wire wouldn't retract, so i attempted to remove the whole device, but only the body would pull out.The cathlon pulled out most of the way but was snagged just under the skin at the insertion site.I called the provider to the room, we were able to forcefully remove the cathlon, but when measured, there was approximately 2 cm missing.Device pictured is exactly how the device came out of the patients upper arm, sans the cathlon, which was measured and discarded.¿.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide pro guidewire was confirmed.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and was not returned for evaluation.The safety mechanism was engaged.A complete break was observed in the core wire in the vicinity of the needle bevel.The coil wire was elongated at the break site but was intact.Microscopic inspection of the core wire revealed a granular fracture texture with a region of increased luster.Inspection of the needle revealed mechanical damage along the proximal edge of the bevel.The core wire break, needle bevel damage and localized coil wire elongation were consistent with guidewire damage caused by contact between the wire and the needle.Such damage can occur if the insertion angle is steep and the wire is withdrawn against the needle bevel.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported "customer was placing powerglide.When she removed the powerglide, the guidewire was coiled and the catheter was sheared.A piece of the catheter remained in the patient's tissue.They confirmed it was not in the patient's vein." add info rcvd 10/27/2020: ¿i inserted the needle, bevel up, into the skin.Visualized the needle inside the vein, obtained blood flash in the chamber, and deployed the guide wire.It made a clicking sound when it reached the bottom of the device.I then tried to deploy the cathlon and it wouldn¿t advance.I tried once more, and again it wouldn¿t advance.I then attempted to remove the entire device.The guide wire wouldn¿t retract, so i attempted to remove the whole device, but only the body would pull out.The cathlon pulled out most of the way but was snagged just under the skin at the insertion site.I called the provider to the room, we were able to forcefully remove the cathlon, but when measured, there was approximately 2 cm missing.Device pictured is exactly how the device came out of the patients upper arm, sans the cathlon, which was measured and discarded.¿.

• Brand Name: FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10809644
• MDR Text Key: 215326563
• Report Number: 3006260740-2020-20405
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140662
• UDI-Public: (01)00801741140662
• Combination Product (y/n): N
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: F318108PT
• Device Catalogue Number: F318108PT
• Device Lot Number: REER0591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 61