MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.5IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdvs0068 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the leakage was found around the base after stayed flushing although resistance was felt, after priming with heparin saline solution, puncturing into the port and blood return confirmed.There was no reported patient injury.
Additional 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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 22ga x 0.5¿ safestep safety infusion set.Light usage residues were observed throughout the sample and the safety mechanism was engaged.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed emanating from the top of the needle housing.Microscopic inspection of the sample using an ultraviolet light revealed voids within the adhesive coverage within the needle housing, appearing to result in a fluid path.The infusion set leak appeared to have been caused by insufficient adhesive deposition/coverage during device assembly.The device is a supplied component; however, the implicated supplier no longer provides these devices.A lot history review (lhr) of asdvs0068 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the leakage was found around the base after stayed flushing although resistance was felt, after priming with heparin saline solution, puncturing into the port and blood return confirmed.There was no reported patient injury.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.5IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10279950
• Report Number: 3006260740-2020-02434
• Device Sequence Number: 19543550
• Product Code: FPA
• UDI-Device Identifier: 00801741066290
• UDI-Public: (01)00801741066290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0035YN
• Device Lot Number: ASDVS0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1