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
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 3006260740-2020-20293
• Device Sequence Number: 11644096
• Product Code: FOZ
• UDI-Device Identifier: 00801741140600
• UDI-Public: (01)00801741140600
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other