MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SETS; INTRAVASCULAR ADMINISTRATION SET

Model Number 37262E

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/22/2021

Event Type  malfunction  

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 #: 21096075 medical device expiration date: 2024-09-25 device manufacture date: 2021-09-17.Medical device lot #: 21096071 medical device expiration date: 2024-09-23 device manufacture date: 2021-09-17.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 when using the bd smartsite¿ extension sets, the device experienced a mix of product types in a pack.The following information was provided by the initial reporter.The customer stated 30-nov-2021 update: can we ensure this is captured for the investigative team- we have mixed stock of this product that is difficult to distinguish since the packaging is exactly the same.We have had multiple leaks and poor connection with the bad lot.

Event Description

It was reported when using the bd smartsite¿ extension sets, the device experienced a mix of product types in a pack.The following information was provided by the initial reporter.The customer stated (b)(6) 2021 update: can we ensure this is captured for the investigative team- we have mixed stock of this product that is difficult to distinguish since the packaging is exactly the same.We have had multiple leaks and poor connection with the bad lot.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-12-31.H6: investigation summary two samples were received for quality investigation.The customer complaint of packaging issue - product issue could not be verified.Although, the male luer adapter connector at the end of the extension sets are different on the two sets, the connection is an approved alternate design, and does not impact the securement and function of the connector.Priming of the extension sets and a simulated infusion test, at a rate of 200 ml/hr was conducted to determine if there was leakage at the male luer connector.There were no issue with leakage observed during the evaluation.A device history record review for model 37262e lot number 21096075 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 37262e lot number 21096071 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined because the failure reported not being replicated.

• Brand Name: BD SMARTSITE¿ EXTENSION SETS
• 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: 13044197
• MDR Text Key: 283836986
• Report Number: 9616066-2021-52611
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403235274
• UDI-Public: 50885403235274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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
• Device Operator: Other
• Device Model Number: 37262E
• Device Catalogue Number: 37262E
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/21/2022
• 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