MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 8 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reet0319 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "nurse was attempting to place the line and was not successful so another nurse stepped in and placed it.Once they removed the housing chamber from the catheter they noticed the wire was not sticking out.Multiple xrays and a chest ct were done with no evidence of a radiopaque foreign object seen.After looking closer it appears the wire is looped at the back end of the housing chamber.".

Event Description

It was reported "nurse was attempting to place the line and was not successful so another nurse stepped in and placed it.Once they removed the housing chamber from the catheter they noticed the wire was not sticking out.Multiple xrays and a chest ct were done with no evidence of a radiopaque foreign object seen.After looking closer it appears the wire is looped at the back end of the housing chamber.".

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 the guidewire being ¿looped back¿ within the housing was inconclusive due the state of the sample upon receipt.The product returned for evaluation was one 18ga powerglide pro midline catheter assembly.The sample was received fully disassembled.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The safety mechanism appeared to have been removed from the needle tip.The guidewire was intact and was attached to the upper housing.Microscopic inspection of the guidewire advancer revealed wear marks in the coupler region.Inspection of the guidewire was unremarkable.Following reassembly of the device, the guidewire functioned as intended.The wear marks in the coupler region indicated that the guidewire as initially properly assembled with the advancer; however, the fully disassembled state of the device upon receipt prevented evaluation of the functional state of the device during the reported event.Consequently this complaint is inconclusive at this time.Potential contributing factors to the reported event include attempted guidewire advancement against resistance, such as into tissue.

• Brand Name: FULL KIT 18G X 8 CM WITH PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10759436
• MDR Text Key: 215272297
• Report Number: 3006260740-2020-20293
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140600
• UDI-Public: (01)00801741140600
• 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: 12/28/2020

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: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: F218088PT
• Device Lot Number: REET0319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other