MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120080
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
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, 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 a sheared catheter and guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter assembly.The sample was received with the catheter removed from the needle and the safety mechanism engaged.Blood residue was evident throughout the sample.The catheter exhibited a complete break 4.3cm from the molded joint and the distal end was not returned for evaluation.The guidewire advancer was fully advanced; however, the tip of the wire did not protrude from the needle tip.Following disassembly of the device, inspection of the wire confirmed that it exhibited a complete break proximal of the coil/core region.The distal wire fragment was not returned for evaluation.Microscopic inspection of the distal end of the catheter revealed a sharply defined irregular fracture surface.The break exhibited an angled profile.Microscopic inspection of the break in the guidewire revealed a primarily granular fracture surface with a region of increased luster.Curved shape memory was observed in the vicinity of the break.The catheter and guidewire fractures were consistent with damage caused by contact with the needle tip.Such damage can occur if the catheter is retracted against the needle and if the needle is advanced into the catheter.The product ifu states ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ a lot history review (lhr) of rebz1535 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that guide wire advanced fine, but the catheter slipped out of the bottom of the housing when pushed forward.It was stated that when the clinician noticed this, he pulled the device out, and the guidewire and the catheter had sheared.The clinician was able to retrieve the guidewire as it was still visible outside the skin, however the broken piece of the catheter remained in the patient.The catheter was retrieved in the ir by cutting a 4 inch incision in the patients arm.

• Brand Name: PG PRO 20G 8CM BASIC KIT
• 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: 7539207
• Report Number: 3006260740-2018-01063
• Device Sequence Number: 2512294
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: F120080
• Device Catalogue Number: F120080
• Device Lot Number: REBZ1535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/23/2018
• 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: Required Intervention