MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. J CONNECTOR LOOP; J LOOP

Model Number	385121
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that j connector loop split open during use.The following information was provided by the initial reporter: had a j-loop connector split open while delivering contrast in ct.The rate of delivery was 5 ml per second.
Additional Manufacturer Narrative
H.6.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.A device history review could not be completed as no batch number was provided.H3 other text : see h.10.
Event or Problem Description
It was reported that j connector loop split open during use.The following information was provided by the initial reporter: had a j-loop connector split open while delivering contrast in ct.The rate of delivery was 5ml per second.

• Brand Name: J CONNECTOR LOOP
• Common Device Name: J LOOP
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10388926
• Report Number: 9610847-2020-00235
• Device Sequence Number: 2385697
• Product Code: FPA
• UDI-Device Identifier: 30382903851219
• UDI-Public: 30382903851219
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: Other
• Device Model Number: 385121
• Device Catalogue Number: 385121
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other