MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY, DUAL-LUMEN, 27CM; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number N/A

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

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 of a foreign material in a kit is confirmed and was determined to be manufacturing related.One sealed retro catheter kit was returned for evaluation.A photo of the kit label as well as a close up photo of the kit was also returned for evaluation.An initial visual observation of the returned sample showed the kit was completely sealed.A hair was observed on the catheter within the kit; which appears to match what was shown in the returned photo.A lot history review (lhr) of aszj0006 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer that there was a hair in the sealed packaging.No patient involvement.

• Brand Name: RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY, DUAL-LUMEN, 27CM
• 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 ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6444230
• MDR Text Key: 71403312
• Report Number: 3006260740-2017-00327
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741014079
• UDI-Public: (01)00801741014079(17)190528(10)ASZJ0006
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K022000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: N/A
• Device Catalogue Number: RS27SH32
• Device Lot Number: ASZJ0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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