MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number 7726950

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.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 connector separated from the catheter was confirmed.Based on the information provided and evidence observed on the returned sample, the cause appeared to be associated with an improper attachment of the connector.One red winged connector from a groshong dual lumen central venous catheter was returned for investigation.The connector locking sleeve was attached to the connector.The proximal end of the connector locking sleeve had been advanced up to the connector wings.No portion of the extension leg was observed between the connector locking sleeve and the red connector, which indicates that the connector separated from the extension leg tubing instead of the extension leg tubing breaking while it was attached to the connector.The groshong catheter was not returned for investigation.It was reported that the catheter was repaired.The connecting features of both the red winged connector and connector locking sleeve were within specification and no damage was observed on the returned components.It appears that the connector was not properly assembled on the catheter.The ifu provides both written and illustrated connector securement instructions to prevent separation of the connector from the groshong dual lumen extension legs.Besides the three complaints reported from this facility, no other complaints were reported with this lot number.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.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.A lot history review (lhr) of rebq1592 showed two other similar product complaints from this lot number.(b)(4).

Event Description

It was reported that after the line was placed one of the ports fell off and was repaired.No other information provided.No patient harm reported.

• Brand Name: GROSHONG 9.5 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6835443
• MDR Text Key: 84386780
• Report Number: 3006260740-2017-01471
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/09/2017,08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: REBQ1592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2017
• Distributor Facility Aware Date: 06/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61