MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY WIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1194108D

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/04/2017

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 rebs0065 showed two other similar product complaint(s) from this lot number.Both complaints for this lot number (rebs0065) have been reported from the same facility.

Event Description

It was reported by the facility, via the sales rep, that the nurse was working with a patient and when she split the introducer, it did not fully split.She was able to use the dilator to push into the unbroken area and cut the area with a scalpel, so she would not cut the picc.

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 an improper peel was confirmed, and was determined to be manufacturing related.One 4.5 fr microintroducer sheath was returned for investigation.The tabs had been split and the sheath had been peeled.The tabs split unevenly, which resulted in a ring of orange material that remained attached to one tab after the introducer was split apart.The head of the tack used to secure the sheath to one of the peel tabs was exposed due to the uneven peel.The complaint sample was forwarded to the manufacturing facility for further review.(b)(4) evaluation: the complaint ¿the introducer, it did not fully split¿ is confirmed.On one of the parts of the sheath was present part of the molding.This part was an excess of resin produced during the molding process.The cause of this is manufacturing related.A lot history review (lhr) of rebs0065 showed two other similar product complaint(s) from this lot number.Both complaints for this lot number (rebs0065) have been reported from the same facility.

Event Description

It was reported by the facility, via the sales rep, that the nurse was working with a patient and when she split the introducer, it did not fully split.She was able to use the dilator to push into the unbroken area and cut the area with a scalpel, so she would not cut the picc.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY WIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6819055
• MDR Text Key: 83745722
• Report Number: 3006260740-2017-01440
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510
• 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: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 1194108D
• Device Catalogue Number: 1194108D
• Device Lot Number: REBS0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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