MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REPLACEMENT CONNECTOR FOR 4F GROSHONG NXT CLEARVUE PICC WITH EXTENSION LEG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recq0692 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that catheter could not pass through oversleeve portion of extension tubing; a foreign matter was observed in the middle of the oversleeve portion.

Event Description

It was reported that catheter could not pass through oversleeve portion of extension tubing; a foreign matter was observed in the middle of the oversleeve portion.

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 lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material within the connector is confirmed but the exact cause could not be determined.One photo sample of what appears to be the distal section of a 4 fr groshong two-piece connector was provided for evaluation.The photo shows a top view down the bore of the distal section of the connector.An object appears to be present within the bore; however, it cannot be clearly identified from the photo provided.The material and the source from which it originated could not be determined; therefore, the exact cause remains unknown.Based on the description of the reported event, possible contributing factors include introduction of material prior to kit packaging or after component use.The photo has been forwarded to the manufacturing facility for further evaluation.Reynosa evaluation complaint due to ¿foreign matter was observed in the middle of the oversleeve portion¿ was confirmed but the exact cause is unknown.According with the photo evaluation performed at reynosa facility and photo evaluation performed by vad field assurance the following was concluded: an object was found to be deposed within the bore of the distal connector; however, it cannot be clearly identified.Contamination during the manufacturing process may be a potential root cause/contributor to the observed foreign material.However, no findings from the dhr review indicated a manufacturing/processing related event.Therefore, as the definitive root cause or source of this contamination could not be determined the cause of this condition remains unknown.A lot history review (lhr) of recq0692 showed no other similar product complaint(s) from this lot number.

• Brand Name: REPLACEMENT CONNECTOR FOR 4F GROSHONG NXT CLEARVUE PICC WITH EXTENSION LEG
• Type of Device: 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: 10168137
• MDR Text Key: 195599105
• Report Number: 3006260740-2020-02095
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741075261
• UDI-Public: (01)00801741075261
• Combination Product (y/n): N
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 7812400
• Device Lot Number: RECQ0692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2020
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1