MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 18G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F318107T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 following were reviewed as part of this investigation: patient severity, frequency 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 a damaged guidewire was confirmed, but the exact cause was unknown.The deployment system for an 18g powerglide pro catheter was returned for investigation.The powerglide catheter had been removed from the needle and was not returned with the deployment system.The safety mechanism was engaged and locked over the needle tip.The guidewire push-off button was in the advanced position.A yellow colored residue was observed on the deployment system.No portion of the guidewire was extending from the needle.No portion of the guidewire was observed in the handle.The deployment system was disassembled and the guidewire was not found within the handle.Adhesive was found where the guidewire had been attached to the handle.The coupler exhibited evidence that the guidewire had been attached.It was reported that the guidewire would not retract after inserting the catheter into the vein block during a demonstration.The guidewire was reportedly lodged inside the purple hub.Since the guidewire and catheter were not returned for investigation, the cause of the complaint was not determined.A lot history review (lhr) of rebx2397 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The tm reported that during demonstration of the powerglide the guidewire would not retract after inserting the catheter into the vein block.It was stated the guidewire was lodged inside the purple hub (completely removed from the housing).
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 a damaged guidewire was confirmed and was determined to be manufacturing related.The deployment system for an 18g powerglide pro catheter was returned for investigation.The powerglide catheter had been removed from the needle and was not returned with the deployment system.The safety mechanism was engaged and locked over the needle tip.The guidewire push-off button was in the advanced position.A yellow colored residue was observed on the deployment system.No portion of the guidewire was extending from the needle.No portion of the guidewire was observed in the handle.The deployment system was disassembled and the guidewire was not found within the handle.Adhesive was found where the guidewire had been attached to the handle.The coupler exhibited evidence that the guidewire had been attached.It was reported that the guidewire would not retract after inserting the catheter into the vein block during a demonstration.The guidewire was reportedly lodged inside the purple hub.The catheter handle was forwarded to the manufacturing facility for further review.Reynosa evaluation: the complaint due to ¿guidewire was lodged inside the purple hub¿ was confirmed.According with visual evaluation that showed that the guidewire was misassembled.The cause of this complaint is manufacturing related.A lot history review (lhr) of rebx2397 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The tm reported that during demonstration of the powerglide the guidewire would not retract after inserting the catheter into the vein block.It was stated the guidewire was lodged inside the purple hub (completely removed from the housing).

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• 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: 7467268
• Report Number: 3006260740-2018-00823
• Device Sequence Number: 13761419
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: Other
• Device Model Number: F318107T
• Device Catalogue Number: F318107T
• Device Lot Number: REBX2397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1