MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 3F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.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 catheter detached from the hub during chemotherapy infusion.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 that the catheter detached from the hub was confirmed and the cause appeared to be associated with use.One 3fr single lumen per-q-cath picc was returned for investigation.The picc was received in two segments.The catheter broke at the distal end of the taper in the molded hub.The 3fr catheter segment was 32.6cm in length.The returned sample exhibited evidence of use.Sutures remained tied to the suture wings.The t-lock extension set remained attached to the catheter hub, but the stylet had been removed.Residue from use was observed on the t-lock extension set.The printed zero mark was partially worn.The adjoining ends of the catheter were microscopically examined and were noted to be granular.A portion of the external surface of the 3 fr tubing exhibited a polished surface just distal to the break site.The characteristics observed in the tubing at the break site indicate that the catheter was kinked or flexed during use.This type of damage can occur if the catheter is in a location that is vulnerable to bending, which can eventually cause the tubing to split with repeated flexing and kinking.No defects related to the manufacturing process were noted on the complaint sample.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
Event or Problem Description
It was reported that the catheter detached from the hub during chemotherapy infusion.No reported patient injury.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.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 that the catheter detached from the hub was confirmed and the cause appeared to be associated with use.One 3fr single lumen per-q-cath picc was returned for investigation.The picc was received in two segments.The catheter broke at the distal end of the taper in the molded hub.The 3fr catheter segment was 32.6cm in length.The returned sample exhibited evidence of use.Sutures remained tied to the suture wings.The t-lock extension set remained attached to the catheter hub, but the stylet had been removed.Residue from use was observed on the t-lock extension set.The printed zero mark was partially worn.The adjoining ends of the catheter were microscopically examined and were noted to be granular.A portion of the external surface of the 3 fr tubing exhibited a polished surface just distal to the break site.The characteristics observed in the tubing at the break site indicate that the catheter was kinked or flexed during use.This type of damage can occur if the catheter is in a location that is vulnerable to bending, which can eventually cause the tubing to split with repeated flexing and kinking.No defects related to the manufacturing process were noted on the complaint sample.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
Event or Problem Description
It was reported that the catheter detached from the hub during chemotherapy infusion.No reported patient injury.

• Brand Name: PER-Q-CATH PLUS PICC 3F SINGLE-LUMEN PICC
• 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: 8076127
• Report Number: 3006260740-2018-03240
• Device Sequence Number: 1638007
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2020

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: 4133105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 10/27/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 11/01/2020
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/23/2019; 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1