MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR; ADMINISTRATION SET

Catalog Number 515302

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 a crack was found in the tubing of the bd phaseal ¿secondary set c61 with a built-in phaseal¿ connector, before use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation: dhr review: no ncr's were registered on this lot.This product is not assembled or packaged in bd (b)(4) plant.The process performed in our plant is the sealing of the membrane on the connector.Then this component is sent to a subcontractor (b)(4) to be assembled and packaged.The inspections performed by the supplier are established according internal procedures.In june 2017 this product was transferred to a different manufacturing site (b)(4).After sterilization, product is sent to (b)(4) plant where visual inspection of pallets is performed.The information of this complaint was sent to the subcontractor for investigation.The subcontractor explains that "previous investigations into complaints of this nature have indicated that this type of damage is consistent with that caused when the tubing is caught in the heat seal of the packaging machine.¿ (¿) ¿a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 04002070377 product in the past 12 months.¿ packaging error: this product is not assembled or packaged in bd (b)(4) plant.The process performed in our plant is the sealing of the membrane on the connector.Then this component is sent to a subcontractor (b)(4) to be assembled and packaged.The inspections performed by the supplier are established according to sb1743 current version.In june 2017 this product was transferred to a different manufacturing site (b)(4).After sterilization, product is sent to (b)(4) plant where visual inspection is performed according to fr-109 procedure: inspection: visual, aql %:n/a, defect: pallet and unit packages free of damages.Conclusion: the information of this complaint was sent to carefusion for investigation.(complaint (b)(4)).According to carefusion report: a 04002070377 sample was not available for investigation; however the customer confirmed that the sample was from lot 527563.The customer forwarded a photograph of the affected product; analysis of the photograph confirmed the customer's experience as the tubing was noted to be sliced and partly compressed.Previous investigations into complaints of this nature have indicated that this type of damage is consistent with that caused when the tubing is caught in the heat seal of the packaging machine.If the set is not coiled in the packaging nest correctly, the seal around the edge of the packaging can be compromised by the tubing protruding out of the packaging.The tubing would then be caught in the packaging heat seal and would be cut by the packaging machine.The quality team at the manufacturing site has been informed of this report and will continue to monitor the incoming feedback and remain vigilant to issues of this nature during future production.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 04002070377 product in the past 12 months.

• Brand Name: BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6992082
• MDR Text Key: 91384456
• Report Number: 3003152976-2017-00097
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K972527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 515302
• Device Lot Number: 527563
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• 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
• Patient Outcome(s): Other