MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4132100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2018
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 rebw2186 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when priming the picc prior to insertion, the facility noticed a pinhole leak around the 10cm mark.This device was not used on a patient.They opened another picc and it was placed successfully.
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 confirmed but the exact cause is unknown.One 2 fr perqcath catheter was returned for investigation.The t-lock and stylet assembly was returned within the catheter.The catheter length was approximately 30.4 cm.Microscopic observation of the distal end of the catheter revealed the tip to be crimped.The cause of the crimped catheter end is unknown.A longitudinal split was observed approximately 20.5 cm from the distal end of the winged hub.The catheter was infused with water using a 12 ml syringe and a spraying leak was observed from the split location.No water was observed to flow out of the distal end.Based on the description of the reported event and condition of the returned sample, possible contributing factors include stylet damage and over-pressurization.The complaint of a leak is confirmed but the cause is unknown.A lot history review (lhr) of rebw2186 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when priming the picc prior to insertion, the facility noticed a pinhole leak around the 10cm mark.This device was not used on a patient.They opened another picc and it was placed successfully.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY
• 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: 7448175
• Report Number: 3006260740-2018-00768
• Device Sequence Number: 13863672
• Product Code: LJS
• UDI-Device Identifier: 00801741035210
• UDI-Public: (01)00801741035210
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 4132100
• Device Catalogue Number: 4132100
• Device Lot Number: REBW2186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1