MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redt2740 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the catheter had a hole in the line that caused all the saline to leak out and not allow the sherlock to pick up the signal from the catheter.".
Event or Problem Description
It was reported "the catheter had a hole in the line that caused all the saline to leak out and not allow the sherlock to pick up the signal from the catheter.".
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, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: this complaint is unconfirmed because the issue could not be reproduced on the returned sample.The product returned for evaluation was a 4fr d/l powerpicc catheter.The catheter was received in two segments.The proximal segment contained the luer adaptors, extension legs, molded suture hub and the catheter to the 13cm depth marking.The other piece of returned material was the catheter tubing from just proximal of the 35cm depth marking to past the 54cm depth marking.The catheter shaft from the 14cm depth marking through the 34cm depth marking was not returned for evaluation.Red residual material was seen within both lumens and the proximal segment appeared to hold a curved radius in the catheter tubing around the 2cm depth marking.A circumferential impression was seen and felt at the 2cm and 52cm depth markings.When the catheter was manipulated by the investigator, the catheter would preferentially kink in these locations.It is likely that the catheter had been kinked previously.Microscopic examination of the ends of all the tubing fragments were examined and contained regular striations and a glossy veneer.It appeared that all the tubing ends had been cut with a sharp instrument.When an attempt was made to flush the proximal catheter segment with water from a 12cc syringe, the purple lumen was patent to infusion.Initially the red lumen was occluded.Residual material was flushed out and then the lumen became patent.When an attempt was made to flush the distal catheter segment with water from a 12cc syringe, both lumens were patent to infusion.The distal ends of the catheter segments were clamped, and the catheter segments were flushed against the occlusions.No leaks were detected in either catheter segment.As no leaks were detected, this complaint will be considered unconfirmed at this time.It is unknown if the leak occurred in the catheter tubing segment that was not returned for evaluation.Possible contributing factors that can lead to a leak in the catheter include sharp instrument damage, material fatigue, tensile (pulling) damage, and over-pressurization.H3 other text : evaluation findings are in section h.11.

• Brand Name: DOT PROV SP 4F DL MAX
• Common Device Name: 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: 10759225
• Report Number: 3006260740-2020-20288
• Device Sequence Number: 4177538
• Product Code: LJS
• UDI-Device Identifier: 00801741134166
• UDI-Public: (01)00801741134166
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: S1274108PD
• Device Lot Number: REDT2740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other