MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F TPS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 2194108

Device Problems Disconnection (1171); Unable to Obtain Readings (1516)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rees1334 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(4).Device not returned for evaluation.

Event Description

It was reported the external ecg worked perfectly, but suddenly lost internal ecg connection.No other information was provided.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of losing the internal ecg signal could not be verified outside the clinical setting and with the condition of the item returned for investigation.One 3cg stylet was returned for investigation.The stylet had been removed from the catheter and was received with the t-lock extension set attached to the wire.The stylet was kinked at the proximal end of the septum on the t-lock extension set.A microscopic examination revealed the presence of conductive epoxy at the distal end of the stylet.The core wire was continuous through the polyimide tubing.Evidence of a kink was observed in the polyimide tubing 2.1cm from the distal tip of the stylet.It could not be determined if this kink affected the signal during use.A continuity and resistance test revealed that the product was within specification.Complications associated with the clinical setting that cannot be replicated in the lab may have affected the functional performance of the device.It is unknown if there was poor continuity with the electrodes and their connections.The gray fin with red and black lead wires was not returned for investigation.Since the reported event could not be verified on the returned sample, the complaint was inconclusive and the cause of the alleged problem could not be determined.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported the external ecg worked perfectly, but suddenly lost internal ecg connection.No other information was provided.

• Brand Name: POWERPICC SOLO 4F TPS
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11024162
• MDR Text Key: 222761642
• Report Number: 3006260740-2020-20974
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2194108
• Device Lot Number: REES1334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other