MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 18G 10CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F118101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of guidewire complications was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter device.The sample was received completely disassembled.Blood residue was observed within the housing and needle safety mechanism.The safety mechanism was engaged over the needle tip.The guidewire exhibited a kink near the distal end.Microscopic inspection of the distal end of the wire revealed the weld tip to be intact.Blood residue was observed between the kinked region and the distal end of the wire.Microscopic inspection of the guidewire coupler revealed superficial scoring marks.The usage residues, guidewire kink and marks on the coupler were consistent with the guidewire being advanced against resistance during attempted use.Such resistance can occur if guidewire advancement into tissue is attempted and can result in guidewire damage and detachment from the advancer.A lot history review (lhr) of rebx0282 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the nurse placed the powerglide catheter and upon removal of the plastic casing there was no guidewire external of the safety.Completed scans were reported to show no guidewire left inside the patient.It was stated risk assessment dissembled the plastic casing and determined the wire was intact, but allegedly looped in the plastic casing and had retracted through the safety needle area.There was no reported patient harm.

• Brand Name: DOT PG PRO 18G 10CM FULL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7516918
• Report Number: 3006260740-2018-00961
• Device Sequence Number: 11149133
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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 Model Number: F118101
• Device Catalogue Number: F118101
• Device Lot Number: REBX0282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1