MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3276135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
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 recn1189 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the as the nurse and doctor were prepping the picc for insertion, it was found the catheter hub clamp was faulty and leaking.A new set was opened and the procedure was completed without further incidence.
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 a damaged clamp was confirmed and the cause appeared to be supplier related.One 6 fr d/l powerpicc was returned for investigation.The catheter had been trimmed at the 43cm depth mark.The clamp on the extension leg with the purple connector was damaged.A microscopic examination of the clamp revealed material deformation that was consistent with shearing.It appeared that the clamp was damaged during the molding process.No damage was observed on the adjacent clamp tag.A functional test revealed that fluid bypassed the closed clamp.A supplier incident report was sent to supplier, regarding this incident, as the clamp is a supplied component.A lot history review (lhr) of recn1189 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the as the nurse and doctor were prepping the picc for insertion, it was found the catheter hub clamp was faulty and leaking.A new set was opened and the procedure was completed without further incidence.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7793312
• Report Number: 3006260740-2018-02114
• Device Sequence Number: 11281708
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 05/31/2022
• Device Model Number: 3276135
• Device Catalogue Number: 3276135
• Device Lot Number: RECN1189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1