MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV PLUS TRAPEZOIDAL PAD, CLAMSHELL RETAINER, MACRO BORE 6IN LUER LOCK E; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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 is pending evaluation.Results are expected soon.A lot history review (lhr) of judy0304 showed three 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 the tubing part of the statlock iv plus has been breaking.It was reported this occurred with three devices.This addresses the second.
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 ¿the tubing part of the statlock iv plus has been breaking¿ was confirmed; however, the root cause was not identified.The product returned for evaluation was two statlock extension sets.Use residues were observed throughout both samples.A needleless injection cap was attached to the first sample (sample 1).The male luer adapters were detached from both extension tubes.Both samples exhibited adhesive residue covering the distal 0.5cm of tubing.Microscopic inspection of both samples confirmed the presence of adhesive residue on both samples.Tactile inspection of the sample did not reveal any tensile weakness.The presence of adhesive residue suggested that adhesive was applied during device assembly.The lack of tensile weakness indicated that the bond failed without excessive tensile stress.Potential contributing factors include chemical exposure and poor bond curing.A lot history review (lhr) of judy0304 showed three 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 the tubing part of the statlock iv plus has been breaking.It was reported this occurred with three devices.This addresses the second.

• Brand Name: STATLOCK IV PLUS TRAPEZOIDAL PAD, CLAMSHELL RETAINER, MACRO BORE 6IN LUER LOCK E
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10175291
• Report Number: 3006260740-2020-02130
• Device Sequence Number: 2630285
• Product Code: FPA
• UDI-Device Identifier: 00801741081699
• UDI-Public: (01)00801741081699
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K980994
• 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): 08/19/2020

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: 10/28/2022
• Device Model Number: N/A
• Device Catalogue Number: IV0221
• Device Lot Number: JUDY0304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1