MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SALINE NORMAL 3ML PLASTIC TUBE; REAGENT, GENERAL PURPOSE

Catalog Number 215439

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

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 the label was illegible with saline normal 3ml plastic tube.The following information was provided by the initial reporter: (2 of 2 complaints).Folded/stained/wrinkled labels.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-jun-23 investigation summary: the batch history record review for batch 1072960 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and torquing processes were within specifications.Qc inspection and testing were satisfactory at time of release.The release testing that is performed on this product does include media appearance.No foreign objects were observed in qc samples at the time of release.If foreign matter had been noted during qc testing, the product would have been placed on quality notification and further analysis including 100% inspection of the batch would have been conducted.Color and clarity of this product is also evaluated prior to release to ensure to ensure that they conform to typical levels.The appearance of this batch was satisfactory per internal procedures.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and no other complaints have been taken on this batch per customer.Retention samples from batch 1072960 were available for inspection.No media defects were observed in 10/10 retention samples.There were 10/10 properly affixed labels one label per tube.For investigation of fill volume all 10/10 tubes were measured using a water blank tube with the acceptable fill volume.All 10/10 tubes measured at the acceptable fill volume level.For further investigation two retentions were tested one tube was placed at 20-25 degree celsius and one tube was placed at 33¿37-degree celsius incubation for a total of seven days.By the seventh day of incubation no microbial growth or particles were observed in either tube.No photos were received from this batch to assist with the investigation for this batch.Two return tubes were also incubated.One tube at 20-25 degree celsius and one tube at 33-37 degrees celsius.At the end of a seven-day incubation period no microbial growth was observed.

Event Description

It was reported that the label was illegible with saline normal 3ml plastic tube.The following information was provided by the initial reporter: (2 of 2 complaints) folded/stained/wrinkled labels.

• Brand Name: SALINE NORMAL 3ML PLASTIC TUBE
• Type of Device: REAGENT, GENERAL PURPOSE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12155871
• MDR Text Key: 263146954
• Report Number: 1119779-2021-01155
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/02/2022
• Device Catalogue Number: 215439
• Device Lot Number: 1072960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2021
• 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