MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F BASIC TRAY WITH MICROI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1396118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
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 following were reviewed as part of this investigation: patient severity, trend 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 luer adapter was confirmed; however, the root cause was not identified.The product returned for evaluation was one two photographs which depicted a portion of t/l powerpicc solo catheter.Both photographs depicted the luer adapters and part of the extension tubes.Usage residues were evident in the photographs.A luer lock syringe was attached to the grey luer adapter in the second photograph.A longitudinally aligned split was evident in the grey luer adapter in both photographs.The split extended from the threads almost to the transition to blue.The fracture appeared to be sharply defined and irregular.While luer adapter damage was evident in the submitted photographs, inspection of those photographs was insufficient to identify the root cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include forceful insertion of a tapered object into the luer orifice and material embrittlement.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the picc was noted to be leaking on flushing on the 11/6 from a crack in the grey lumen during an als.Covered with opsite to seal, and medical decision to leave insitu as very difficult access and ongoing hemodynamic instability.Removed on the (b)(6) and midline inserted.On inspection looks like someone has either overtightened a connector, or used forceps to remove maybe.There was no reported patient injury.
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 cracked luer connector was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was a 6fr t/l powerpicc solo catheter.The gray solo connector cap contained a longitudinal crack leading from the proximal edge of the hub, through the mold injection gate, and only affected the gray cap of the connector.Blood-like usage residue was seen throughout the device.The crack was then forced open in order to inspect the inner fracture surface.Microscopic examination of the fracture surfaces found that they were rough and granular in nature and topographically complex.The observed fracture features were consistent with internal investigation.However, it is unknown if the device was manufactured prior to, or following, the associated corrective actions as no lot number was returned.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the picc was noted to be leaking on flushing on the 11/6 from a crack in the grey lumen during an als.Covered with opsite to seal, and medical decision to leave insitu as very difficult access and ongoing hemodynamic instability.Removed on the 12/6 and midline inserted.On inspection (see photos) looks like someone has either overtightened a connector, or used forceps to remove maybe.There was no reported patient injury.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 6F BASIC TRAY WITH MICROI
• 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: 7664096
• Report Number: 3006260740-2018-01633
• Device Sequence Number: 2770818
• Product Code: LJS
• UDI-Device Identifier: 00801741034770
• UDI-Public: (01)00801741034770
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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 Model Number: 1396118
• Device Catalogue Number: 1396118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1