MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that upon insertion of the per-q-cath the nurse flushed it and noted a hole in the catheter.The nurse completed the procedure with another device.The original catheter was cut into three pieces to exchange it.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 leak is inconclusive due to poor sample condition.One 2 fr single lumen per-q-cath was returned for evaluation.An initial visual observation showed a clamp indentation and adhesive residue on the extension leg of the t-lock.The catheter appeared to have been trimmed approximately 0.7 cm distal to the distal end of the strain relief.The sample was flushed and pressurized with a 12 ml syringe of water.The sample was found to be patent to infusion and aspiration, however, no leaks were found.A microscopic observation revealed no holes or splits in the catheter.Striations were observed on the surface of the distal end of the catheter, indicating it was cut with a ground-sharpened instrument.No leaks were found in the returned sample; however, since only approximately 0.7 cm of the catheter was returned for evaluation, the complaint of a leak is inconclusive at this time.Possible causes of a leak include stylet damage, sharp instrument damage, and over pressurization.A lot history review (lhr) of rebt1329 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that upon insertion of the per-q-cath the nurse flushed it and noted a hole in the catheter.The nurse completed the procedure with another device.The original catheter was cut into three pieces to exchange it.No reported patient injury.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY
• 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: 7039769
• Report Number: 3006260740-2017-02054
• Device Sequence Number: 2037137
• Product Code: LJS
• UDI-Device Identifier: 00801741035210
• UDI-Public: (01)00801741035210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: N/A
• Device Catalogue Number: 4132100
• Device Lot Number: REBT1329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1