MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 19G X 0.75IN 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asdrf076 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that "the port needles changed.I was able to obtain a new and old port needle.The difference is the old port needles had blue caps and white clips.They were made in mexico.The new needles have white caps and clear clips and are made in (b)(6).Now that the newer needles are making there ways into all of the ahs infusion centers we are seeing more and more cracks.".
Event or Problem Description
It was reported by the facility that "the port needles changed.I was able to obtain a new and old port needle.The difference is the old port needles had blue caps and white clips.They were made in mexico.The new needles have white caps and clear clips and are made in china.Now that the newer needles are making there ways into all of the ahs infusion centers we are seeing more and more cracks.".
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, 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 a leaking infusion set is inconclusive due to poor sample condition.Two photo samples of two 19 x 0.75 in miniloc infusion sets were returned for investigation.The samples appear to be in sealed packaging.The photos show the front and back of the infusion set packaging.The product lot number is asdrf076.The condition of the samples or presence of a leak could not be determined from the photos provided.Since the reported issue could not be confirmed from the photo samples provided, the complaint remains inconclusive at this time.A lot history review (lhr) of asdrf076 showed no other similar product complaint(s) from this lot number.

• Brand Name: MINILOC SAFETY INFUSION SET 19G X 0.75IN 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: 9848692
• Report Number: 3006260740-2020-00878
• Device Sequence Number: 3432572
• Product Code: FPA
• UDI-Device Identifier: 00801741048005
• UDI-Public: (01)00801741048005
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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 Model Number: N/A
• Device Catalogue Number: 0681934
• Device Lot Number: ASDRF076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1