MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV SELECT MACRO 6IN FOR LOW PRESSURE POWER INJECTORS W/SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
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 jufr2957 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "per critical care hcp: the extension piece broke from the luer lock ending and disconnected from the patient¿s iv catheter hub portion." add info rcvd: 08/18/2021: date of occurrence: august 1st.Placement date: july 31st.Explant date: we removed after the tubing broke in 8/1/21.Was there any blood exposure: lingering blood in the tubing and minimal at the insertion site.Was there patient harm reported?: none at this time.
Event or Problem Description
It was reported "per critical care hcp: the extension piece broke from the luer lock ending and disconnected from the patient¿s iv catheter hub portion." add info rcvd: date of occurrence: august 1st.Placement date: (b)(6) 2021.Explant date: we removed after the tubing broke in (b)(6) 2021.Was there any blood exposure: lingering blood in the tubing and minimal at the insertion site.Was there patient harm reported?: none at this time.
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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached hub is confirmed and was determined to be manufacturing related.One extension set was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal luer hub was found to be missing.A ring of what appears to be adhesive was observed just proximal to the distal end of the tubing.A microscopic observation revealed little to no adhesive on the distal end of the tubing, distal to the ring of adhesive.Striations were observed on the distal end of the tubing, which was found to be flat and somewhat polished, suggesting it was the manufactured end of the tubing.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.

• Brand Name: STATLOCK IV SELECT MACRO 6IN FOR LOW PRESSURE POWER INJECTORS W/SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12377363
• Report Number: 3006260740-2021-03566
• Device Sequence Number: 11863834
• Product Code: FPA
• UDI-Device Identifier: 00801741082030
• UDI-Public: (01)00801741082030
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K090134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: IV0563P
• Device Lot Number: JUFR2957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown