MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC PORT ACCESS KIT 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
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 redy3541 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported "i was notified by pediatrics about an issue that has occurred with the needle in the miniloc port access kit lot # redy3541 20 ga.75¿.Rn indicated that the needle would not advance past half way.No patient harm".
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, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a defective safety mechanism was unconfirmed as the problem could not be reproduced.One 20 ga x 0.75 in miniloc infusion set was returned for evaluation.The safety mechanism was returned fully activated over the needle.No apparent evidence of bends or deformation was observed which may have impacted the functionality of the safety mechanism.Microscopic observation of the needle tip did not reveal it to be bent or barbed.The activation issue or resistance experienced during use of the device could not be replicated as the safety mechanism was returned successfully activated over the needle.Since no apparent mechanical interference issues were observed which may have contributed to the reported event were observed, the complaint could not be confirmed.Dried residual material and handling method may have contributed to increased resistance experienced during attempted activation.A lot history review (lhr) of redy3541 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported "i was notified by pediatrics about an issue that has occurred with the needle in the miniloc port access kit lot # redy3541 20 ga.75¿.Rn indicated that the needle would not advance past half way.No patient harm".

• Brand Name: MINILOC PORT ACCESS KIT 20G 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: 10121443
• Report Number: 3006260740-2020-01975
• Device Sequence Number: 3083342
• Product Code: FPA
• UDI-Device Identifier: 00801741044656
• UDI-Public: (01)00801741044656
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 2682034
• Device Lot Number: REDY3541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1