MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD GP SERIES INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 60693E

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd gp series infusion set separated.The following information was received by the initial reporter with the verbatim: the nurse had prepared the infusion set during surgery.After the surgery, while preparing for patient transport, and while mounting the set in the pump, the set was split in two, disconnecting at the top blue adapter that goes into the infusion pump.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: one 60693e sample was received for investigation of pr 9179406, in which the customer has stated: "the set is spilt in two under the blue adapter that goes in the pump." the sample was received with residual fluid present in the line.No packaging was received with the sample; however, the customer has indicated that the lot number is 1022964.Examination of the sample confirmed the customer's experience as the sample was received in two pieces, with the separation occurring at the upstream joint of the blue upper pumping segment component (appendix 1).Upon closer examination, it was noted that there were minimal signs of residual solvent on the tubing (appendix 2).The details of this feedback were forwarded to the manufacturing site for investigation, where it was determined that the separation is likely to have occurred as a result of an inconsistent amount of solvent having been applied to the tubing during the solvent bonding process; this is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 1022964 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer advocacy feedback database indicates that this is a rare occurrence, with only a small number of similar reports received in the past 12 months against products from this manufacturing site.

Manufacturer Narrative

Correction: the initially reported material number was determined to be exempt from us fda reporting requirements.Please disregard previous submissions.

• Brand Name: BD GP SERIES INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18212635
• MDR Text Key: 329080355
• Report Number: 9616066-2023-02272
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203000681
• UDI-Public: (01)37613203000681
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 60693E
• Device Lot Number: 1022964
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1