MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERMIDLINE 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number P4154108D

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reen3336 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

It was reported the customer was using a powermidline kit and the introducer sheath did not tear.It was stated the customer needed to use scissors to cut open to remove.The customer reported this has occurred three times with this lot number across at least 2 picc/ml prodecuralists.This report addresses the third event.

Event Description

It was reported the customer was using a powermidline kit and the introducer sheath did not tear.It was stated the customer needed to use scissors to cut open to remove.The customer reported this has occurred three times with this lot number across at least 2 picc/ml prodecuralists.This report addresses the third event.

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, labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a difficult to split sheath was confirmed and appears manufacturing related.The product returned for evaluation was a 4.5fr microintroducer sheath.The handles of the introducer had been split and the sheath had been split down one side.On the handle containing the fr size indicator, the sheath material had split circumferentially, approximately at the distal end of the handle.The edge of the split was angular and contained irregular break edges; the longer section of the sheath had broken at the end of the handle while the shorter pieces broke within the handle, 0.06¿ from the distal end of the handle.The handle with the ¿bard¿ indicator contained the rest of the sheath.The sheath material had split all the way, longitudinally on one side.The complete longitudinal tear revealed that the first 0.8¿ of the split, the edges were curled, the last part of the split was very straight.The other side contained a very small longitudinal split (0.09¿ long).Both handles contained evidence that the handles had not split easily, as the break surface of the handles was not a clean straight break.Instead each handle had sections of material that had stretched and broken, as evidenced by the thinness of the material and the crazing seen in the material.The poor breakability and peelability will be considered manufacturing related.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERMIDLINE 4F
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10988562
• MDR Text Key: 221289404
• Report Number: 3006260740-2020-20841
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P4154108D
• Device Catalogue Number: P4154108D
• Device Lot Number: REEN3336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other