MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F TL HF 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional 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 reaz1037 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reaz1037) have been reported from the same facility.
Event or Problem Description
Per sales rep, the facility reported that on (b)(6) 2017 while placing a picc line, the (red) handle broke off when attempting to break the peel away introducer.The vascular access nurse was unable to grasp the remaining grey portion of the introducer and used sterile hemostats to peel away the remaining catheter at the insertion site.It was stated that this caused excessive trauma at the insertion site.This report addresses patient three.
Additional 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 split between the peel tabs was confirmed, and was determined to be manufacturing related.One 5 fr microintroducer sheath was returned for investigation.The tabs had been split and the sheath had been peeled.One of the two peel tabs was broken and the sheath tore away from the tack.The tabs split unevenly, which resulted in a ring of red material that remained after the red colored tabs were split apart.The sheath exhibited a uniform and consistent peel.The tack used to secure the sheath to the peel tabs was observed to be centered.A microscopic examination of the fractured surfaces of the sheath revealed that the fracture coincided with the distal end of the tack.Variable material fill was observed in the molded material underneath the tack head.The complaint sample was forwarded to the manufacturing facility for further review.It was determined that 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.Operator¿s awareness was performed and it was documented in the record training (b)(4).A lot history review (lhr) of reaz1037 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reaz1037) have been reported from the same facility.
Event or Problem Description
The facility reported that on (b)(6) 2017 while placing a picc line, the (red) handle broke off when attempting to break the peel away introducer.The vascular access nurse was unable to grasp the remaining grey portion of the introducer and used sterile hemostats to peel away the remaining catheter at the insertion site.It was stated that this caused excessive trauma at the insertion site.This report addresses patient three.

• Brand Name: POWERPICC 5F TL HF 3CG
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6663366
• Report Number: 3006260740-2017-00893
• Device Sequence Number: 816022
• Product Code: LJS
• UDI-Device Identifier: 00801741129568
• UDI-Public: (01)00801741129568(17)180331(10)REAZ1037
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: CK000653
• Device Lot Number: REAZ1037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR