MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD¿ Y-SITE WITH ANTI-SIPHON VALVE SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 30852

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that 116 bd¿ y-site with anti-siphon valve sets from lot 22015632, and 57 sets from lot 22075069 were found with their tubing kinked in the packaging.The following information was provided by the initial reporter: "the infusion tubing is kinked inside the sterile packaging.This will cause the occlusion pressure & alarm appeared during the drug infusion in operating theatre.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22015632.Medical device expiration date: 14-jan-2025.Device manufacture date: 10-jan-2022.Medical device lot #: 22075069.Medical device expiration date: 11-jul-2025.Device manufacture date: 27-jun-2022.Initial reporter phone#: unknown.Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 31-oct-2022.H6: investigation summary two boxes of 30852 samples were received for investigation.The first box contained one hundred and eighteen samples from lot 22015632 of which one sample was received in opened packaging whilst the remaining samples were received in sealed packaging.The second box contained fifty-seven samples from lot 22075069 all in sealed packaging.The feedback provided by the customer indicates the products were received with the tubing kinked.As part of the investigation the customer provided photographs of their experience; a visual inspection of both the photographs and the returned samples confirmed the customer experience as all the returned samples had kinked tubing.The details of this feedback were forwarded to the manufacturing site for investigation.A definitive root cause could not be determined, however kinked tubing typically occurs as a result of inadequate coiling of the set prior to packaging and sterilisation; this is a manual process and it is likely to have occurred due to human error.A review of the production records for lots 22015632 and 22075069 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

Event Description

It was reported that 116 bd¿ y-site with anti-siphon valve sets from lot 22015632, and 57 sets from lot 22075069 were found with their tubing kinked in the packaging.The following information was provided by the initial reporter: "the infusion tubing is kinked inside the sterile packaging.This will cause the occlusion pressure & alarm appeared during the drug infusion in operating theatre.".

• Brand Name: BD¿ Y-SITE WITH ANTI-SIPHON VALVE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15504604
• MDR Text Key: 305710399
• Report Number: 9616066-2022-01437
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011075
• UDI-Public: (01)07613203011075
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 30852
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1