MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE; TRANSPORT CULTURE MEDIUM

Catalog Number 364938

Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

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

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9004601.Medical device expiration date: 2021-01-31.Device manufacture date: 2019-01-04.Medical device lot #: 8215601.Medical device expiration date: 2020-08-31.Device manufacture date: 2018-08-03.Medical device lot #: 8011855.Medical device expiration date: 2020-01-31.Device manufacture date: 2018-01-11.Medical device lot #: 9036662.Medical device expiration date: 2021-02-28.Device manufacture date: 2020-01-31.Medical device lot #: 8215601.Medical device expiration date: 2020-08-31.Device manufacture date: 2021-02-28.Medical device lot #: 9004601.Medical device expiration date: 2021-01-31.Device manufacture date: 2019-01-04.Medical device lot #: 8215601.Medical device expiration date: 2020-08-31.Device manufacture date: 2021-01-31.Medical device lot #: 8011855.Medical device expiration date: 2020-01-31.Device manufacture date: 2018-01-11.Medical device lot #: 9036662.Medical device expiration date: 2021-02-28.Device manufacture date: 2019-02-05.Medical device lot #: 8215601.Medical device expiration date: 2020-08-31.Device manufacture date: 2018-08-03.Medical device lot #: 9004601.Medical device expiration date: 2021-01-31.Device manufacture date: 2019-01-04.Medical device lot #: 8215601.Medical device expiration date: 2020-08-31.Device manufacture date: 2018-08-03.Medical device lot #: 8011855.Medical device expiration date: 2020-01-31.Device manufacture date: 2018-01-11.Medical device lot #: 9036662.Medical device expiration date: 2021-02-28.Device manufacture date: 2019-02-05.Medical device lot #: 8215601.Medical device expiration date: 2020-08-31.Device manufacture date: 2018-08-03.Medical device lot #: 8215601.Medical device expiration date: 2020-08-31.Device manufacture date: 2018-08-03.

Event Description

It was reported before use the bd vacutainer® z (no additive) urine tube there was no label or missing label information ( all packaging levels), foreign matter in tube; biological and non-biological, broken lid/cap, tubes/ extenders with molding defects (non-cosmetic) that can be used.The following information was provided by the initial reporter: ¿the costumer complained about few deficiencies: absence of barcode sticker.The tube interior is dirty.The rubber head is dirty, torn and damaged.The tube is conail and not round bottom as it should be¿.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: (b)(6) 2020.H.6.Investigation: embedded fm-upon evaluation of the 2 actual customer returned sample and the 4 photos, the customer¿s product issue was observed during visual evaluation of the samples and photos.There were no related quality notifications.All process and final inspections comply with specification requirements.A capa# 90580 has been opened for molding defects including embedded fm.Fm - based on evaluation of the customer samples, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.There has been increased awareness for cleanliness and reduction of foreign matter in the plant.A number of projects are in place that will help reduce the potential of introducing fm into tubes.A team has also been established that¿s main focus is fm awareness and reduction.Damaged tube - upon evaluation of the customer¿s sample provided the tube appears to have several scratches on the length of the tube.This is most likely caused by the tube becoming lodged somewhere in the production line, possibly when the tubes are placed in the 300 tube batch trays.Defective stopper molding - the customer¿s product issue was observed during visual inspection of the samples.Since defect occurred in stopper, the stopper manufacturing site was asked to provide details on batch data and possible root cause.A capa# 796739 has been opened for molding defects in stoppers at the manufacturing site.Incorrect tube size - upon evaluation of the customer¿s sample provided there are 2 different tubes present.One round bottom tube and one conical tube, the product specification calls for a round bottom tube.The machine that places tubes into 300 batch tube trays was not removed of prior product before running this production order.Unseated stopper ¿ upon evaluation of the customer¿s sample provided, there are several reasons why stoppers are unseated including under lubing of the stopper and stopper lid damaged.These tubes are to be culled on the line by the operators.Missing label - upon evaluation of the customer returned samples, the customer¿s product issue was observed.This product requires a paper label and the manufacturing line contains a label sensor to detect defects.These defects are culled at the tullip.H3 other text : see h.10.

Event Description

It was reported before use the bd vacutainer® z (no additive) urine tube there was no label or missing label information ( all packaging levels), foreign matter in tube; biological and non-biological, broken lid/cap, tubes/ extenders with molding defects (non-cosmetic) that can be used.The following information was provided by the initial reporter: ¿the costumer complained about few deficiencies: absence of barcode sticker, the tube interior is dirty, the rubber head is dirty, torn and damaged, the tube is conail and not round bottom as it should be¿.

• Brand Name: BD VACUTAINER® Z (NO ADDITIVE) URINE TUBE
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9717812
• MDR Text Key: 188047296
• Report Number: 1917413-2020-00138
• Device Sequence Number: 1
• Product Code: JSL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364938
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 01/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other