MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SL POWERPICC 3CG, MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK0000101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2017
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 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 detached dilator hub was confirmed, and the cause was determined to be manufacturing related.One dilator from a microintroducer was returned for investigation.The dilator was received in two pieces.There was a complete separation of the dilator tubing from the hub.The overall length of the dilator tubing was 4.0¿.A microscopic observation revealed anchor marks in the proximal end of the dilator, which were located 1.5mm and 3.5mm from the proximal end of the tubing.A microscopic observation of the molded hub revealed that the dilator insertion depth within the hub was less than the diameter of the dilator tubing.It appears that the anchors were not captured in the molded hub, which could be attributable to an improper position of the dilator tubing on the pins when molding the hub.The complaint sample will be forwarded to the manufacturing facility for further review.A lot history review (lhr) of reau2296 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, facility reported that the healthcare professional gained access to the patient, placed the wire and proceeded to place the introducer/sheath.When removing the sheath, the introducer was in two pieces.The wand of the introducer was separated from the hub.No injury to the patient reported.

• Brand Name: 4F SL POWERPICC 3CG, MB
• 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: 6332762
• Report Number: 3006260740-2017-00077
• Device Sequence Number: 13623751
• Product Code: LJS
• UDI-Device Identifier: 00801741036255
• UDI-Public: (01)00801741036255(17)180131(10)REAU2296
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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: 01/31/2018
• Device Catalogue Number: CK0000101
• Device Lot Number: REAU2296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1