MAUDE Adverse Event Report: BECTON DICKINSON BD¿ DEHP FREE INFUSION SET; IV TUBING

Catalog Number 590502

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Investigation results: summary: one sample was returned to (b)(4) , lot number 2707261, (b)(4) checked the sample and found there was hair between y-connector body and shrinking film.House sample inspection: (b)(4) inspected 15 pcs of house sample for lot 2707261, no foreign matter was found on the samples.Device history record review: (b)(4) checked manufacturing records including receiving inspection report, process inspection report and finished product test report for lot 2707261, no abnormality was observed.(b)(4) complaint record review: (b)(4) reviewed customer complaint record and there is no repeated same issue from other customer.Y connector assembly process - (b)(4) investigation the process flow of y connector, and found the fm (hair) between y-connector body and shrinking film would have occurred in the manual assembly process of shrinking film with y-connector body & rubber cap.Root cause: the foreign matter of the complaint sample, hair, most likely occurred in the manual assembly process of shrinking film with y-connector body & rubber cap.(b)(4) investigated and concluded that due to insufficient cleanroom protocol cleanliness / dressing standards, production workers in the assembly line might have induced foreign matter (hair) into the products unknowingly.(b)(4) have also reviewed receiving inspection report and i.V set manufacturing process about this case but, there was no abnormal issue.Corrective actions: (b)(4) had quality training on this customer complaint for i.V set assembly line workers and quality inspectors.(b)(4) implement tightened product & process monitoring and strengthening quality inspection for y-connector inspection and i.V set process inspection.(b)(4) conduct cleaning manufacturing line, inspection table and assembly table 3 time a day, before start work, before lunch and after finish work, according to working place clean procedure.(b)(4) enhance cleanroom clothes regulation for all workers (anti-dust inner cap with anti-dust cap) to prevent fm(hair) in the i.V set assembly process.The inner cap could catch hair inside the cap so, hair drop could be prevented.

Event Description

It was reported that foreign matter "hair" was found in a bd¿ dehp free infusion set, specifically in the gap between y-port connections.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD¿ DEHP FREE INFUSION SET
• Type of Device: IV TUBING
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7566665
• MDR Text Key: 110576544
• Report Number: 2243072-2018-00317
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K150059
• 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
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/25/2020
• Device Catalogue Number: 590502
• Device Lot Number: 2707261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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