MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 23 CM 14.5 FR HEMOSTAR STANDARD KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5833730

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2017

Event Type  malfunction  

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 that the dilator would not fit over the wire was confirmed and the damage appeared to be use related.One 0.038¿ guidewire and one vessel dilator from an introducer were returned for investigation.The vessel dilator had been removed from the introducer sheath and the sheath was not returned for investigation.The guidewire was bent 19, 22, and 29 cm from the curve in the j-tip.Dislocations were observed in adjacent coils of the guidewire 0.3 and 1.6 cm from the distal weld tip.A functional test revealed that the proximal end of the guidewire passed through the entire dilator without any resistance until the dilator tip came in contact with the first bend in the wire.The dilator could not be advanced over the bent wire.The outside diameter (od) of the guidewire was measured with calipers and was found to be within specification.Since the damaged guidewire prevented advancement of the dilator, the complaint was determined to be use related since the guidewire had been removed from its hoop, inserted through a needle, and damaged after the needle was removed from the guidewire.Had the wire been damaged before use, the guidewire would not fit through the needle.A lot history review (lhr) of reap2219 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient was going to have device inserted on (b)(6) 2017 and during the insertion procedure, the guidewire could not be re-inserted into the dilator.The j-tip of the guidewire could not pass through and come out at the dilator tip.The radiologist found resistance near the tip portion of the dilator.They had used another manufacturer¿s guidewire and the guidewire tip failed to come out from the dilator tip.No patient injury was reported.

• Brand Name: 23 CM 14.5 FR HEMOSTAR STANDARD KIT
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7068898
• MDR Text Key: 93460491
• Report Number: 3006260740-2017-02148
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 5833730
• Device Catalogue Number: 5833730
• Device Lot Number: REAP2219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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