MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFETY HUBER 20G X 0.75IN WITH NF VALVE SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 585112

Device Problem Partial Blockage (1065)

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

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 of bleedback through the infusion set was inconclusive due to the sample condition. One photograph was provided for investigation. The photo showed one 20g ez huber infusion set being used on a patient. A dressing was attached to the needle housing. The extension set tubing between the needle housing and the y-site, and between the y-site and the proximal clamp was full of what appeared to be blood. The distal clamp appeared to be closed. The proximal clamp was not fully shown in the photo. The proximal end of the proximal clamp, the luer adaptor, and connection made at the luer adaptor were not visible in the photo. Although blood was visible in the extension set tubing, the cause of and the conditions surrounding the reported event were unknown. Potential contributing factors include the pressure gradient within the infusion set, improper connections, and clamp damage. The product ifu states, ¿fully tighten all connections, y-site end caps, or needleless connectors before use. Failure to attach an end cap or appropriate needleless device after removing a male luer locking end cap or needleless connector can result in an embolism or bleeding". A lot history review (lhr) of recn2786 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that port was accessed without difficulty, but blood backed up the length of the tubing. It was stated patient was receiving iv flush infusion at the time.

• Brand Name: SAFETY HUBER 20G X 0.75IN WITH NF VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7539200
• MDR Text Key: 109251335
• Report Number: 3006260740-2018-01064
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 585112
• Device Lot Number: RECN2786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial