MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5FR DL PP MB KIT; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number 1275108D

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 04/21/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaz0762 showed no other similar product complaint(s) from this lot number.

Event Description

Per sales rep, the facility reported that the nurse went to peel away the microintroducer and the right thumb tab broke off leaving a small red piece attached the gray sheath unsplit.It was stated that the nurse had to manipulate the device in order to get it to split.No patient injury was reported.

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 improper introducer separation is confirmed and the cause was determined to be manufacturing related.The returned sample is one 5 fr microintroducer sheath.The sheath has been split and one of the handles has broken from the sheath into two pieces.The sheath itself appears to have split correctly, while a section of the broken handle is attached to the mating handle via the score line.The plastic in the center of the section of unseparated t-handle appears to be thicker than the surrounding sections.The t-handle did not separate correctly and the plastic in the area appears different.Possible causes include molding flaw and tool damage.

Event Description

Per sales rep, the facility reported that the nurse went to peel away the microintroducer and the right thumb tab broke off leaving a small red piece attached the gray sheath unsplit.It was stated that the nurse had to manipulate the device in order to get it to split.No patient injury was reported.

• Brand Name: 5FR DL PP MB KIT
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6573244
• MDR Text Key: 75517381
• Report Number: 3006260740-2017-00621
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034558
• UDI-Public: (01)00801741034558(17)180531(10)REAZ0762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• 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,Followup
• Report Date: 08/04/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 1275108D
• Device Catalogue Number: 1275108D
• Device Lot Number: REAZ0762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 05/18/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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
• Patient Age: 70 YR