MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD T-CONN W/LUER SLIP ADPT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20051E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd t-conn w/luer slip adpt was cracked.The following information was provided by the initial reporter: the pale yellow area cracked.
Additional Manufacturer Narrative
A 20051e product was not available for investigation of pr (b)(4); however, in this complaint lot number was not available.The feedback provided by the customer states that, " the pale-yellow area cracked".No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation; however, in this complaint lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 20051e products in the past 12 months.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation result: one 20051e sample was received without packaging for investigation; blood was present on the t-connector luer and no connecting product was available to aid the investigation.The customer reported that " the pale yellow area cracked".No further information was available to assist the investigation in this instance.Visual inspection of the returned sample confirmed the customer's investigation; the female luer was cracked vertically.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.A definitive root cause could not be determined in this instance, however previous investigations have confirmed similar damage can be caused or contributed to by a combination of different factors, including prolonged use of substances that are aggressive to plastics, over-torque of the component during connection with the male luer, or use of a male luer that is not compliant to iso standards.The quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 20051e products in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD T-CONN W/LUER SLIP ADPT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24460064
• Report Number: 9616066-2026-00521
• Device Sequence Number: 21237782
• Product Code: FPA
• UDI-Device Identifier: 07613203012331
• UDI-Public: (01)07613203012331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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 Catalogue Number: 20051E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 04/23/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown