MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD SAFESTEP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problems Bruise/Contusion (1754); Exsanguination (1841)

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported by the customer via "patient had port placed today and was accessed with huber needle.Later in evening, dressing was noted to be bloody, port was de-accessed by primary rn and bevel of needle found to be bent but intact.Insertion site assessed and some bruising noted, no longer bleeding.Did not appear infiltrated.Re-accessed with new needle, no apparent harm." additional information provided: patient being treated for lymphoma.12/22/2022: the returned sample exhibited a bend that did not allow the safety to successfully engage.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of bent needle was confirmed.The product returned for evaluation was a one 22 ga x 0.5 in safestep infusion set.The returned product sample was evaluated and the needle was observed to be bent at the needle tip.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use, the bend in the needle had occurred away from the needle base which can be caused by device manipulation during/following port access, the needle tip was barbed suggesting contact between the needle and port base an attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass the bent region of the needle.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: BARD SAFESTEP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16186305
• MDR Text Key: 307667628
• Report Number: 3006260740-2022-06076
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 89 KG