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 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 device has not been returned to the manufacturer for evaluation.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.One of the patient has developed a blood stream infection that a line break could be contributed to.
Event or Problem Description
It was reported the tubing part of the statlock iv plus has been breaking.One of the patient has developed a blood stream infection that a line break could be contributed to.
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 broken statlock extension tube was inconclusive because the returned sample was not the originally implicated device.The product returned for evaluation was one statlock iv plus catheter stabilization device.The sample was received in its original sealed packaging.The sample was unremarkable to gross inspection.Microscopic inspection of the extension tubing joints was unremarkable.Tactile inspection of the sample was unremarkable.An attempt to infuse water through the extension tube using a 12ml syringe revealed it to be patent to infusion and aspiration with no observed leaks.No defects or deficiencies were discovered during evaluation of the returned sample; however, the sealed state of the device indicated that it was not the originally implicated device, but was an unused lot sample.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.

• 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: 10175374
• Report Number: 3006260740-2020-02131
• Device Sequence Number: 16735879
• 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): 08/26/2020

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: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1