MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX 20G 8CM BASIC KIT; INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

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 break in the guidewire was confirmed, and the damage appears to be related to use of the device.One powerglide pro deployment system was returned for investigation.The catheter had been removed from the needle and was not returned for investigation.The safety mechanism had been locked over the needle tip.Blood residue was observed in the handle.No portion of the guidewire was protruding from the distal tip of the safety mechanism.The safety mechanism was removed from the needle and the distal tip of the needle was microscopically examined.There was a break in the wire that coincided with the tip of the needle.The distal tip of the wire was not returned for investigation.The fractured end of the wire exhibited necking and a granular tip, which is consistent with a tensile break.The inner edge of the needle bevel exhibited deformation, which is indicative of force between the wire and the needle bevel.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebn2178 showed no other similar product complaint(s) from this lot number.

Event Description

Per sales rep, the facility reported that during placement of the powerglide the wire broke off and remained in the patients subcutaneous tissue.It was stated that the wire was removed in ir and there was no permanent damage to the patient.

• Brand Name: PFLEX 20G 8CM BASIC KIT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6584611
• MDR Text Key: 75761451
• Report Number: 3006260740-2017-00671
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528(17)190131(10)REBN2178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: F120080
• Device Lot Number: REBN2178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1