MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367406

Device Problems No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/11/2021

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 when using the bd vacutainer® sst blood collection tubes there was clogged/blocked instrumentation probes and oil gel globules.This event occurred 10 times.The following information was provided by the initial reporter: translated to english.The customer stated: on the morning of (b)(6) 2021, the customer complained that the instrument alarmed and blocked the needle when the yellow tube was on the machine; the alarm was taken out suspected oil droplets or gel balls were observed in the tube after the yellow tube; take it out with a cotton swab and place it on a paper for observation, it is sticky; the situation confirmed by the sales rep site is true: the investigation is as follows: the general warehouse air conditioning in the hospital: room temperature below 25°; laboratory air conditioner: below 25°; laboratory room temperature: below 25°; laboratory use 2 thermostatic centrifuges: one of them: set temperature: 28°; rpm: 4000; xg: 2784; second station: set temperature 25°, rpm: 4000; xg: 3072; 3: clinical department operation: use an incubator to load blood collection tubes and transport to the laboratory window; needle blockage and bleaching oil samples: 4 cases; customers are bd the quality of the product was questioned.The imported yellow tube was used in the past.Due to the cost of consumables, it was converted to suzhou yellow tube; the color and shape of the separating glue were different, and the quality difference of the separating glue was questioned, worried about affecting the normal use of the instrument, affecting work efficiency and inspection result.(b)(6) 2021 received an update from the sales representative, and the description of the incident was updated as follows: the customer complained that when the yellow tube was on the machine, the instrument alarmed and blocked the needle; after taking out the alarmed yellow tube, it was observed that there were fibrin filaments/lumps in the tube; it was taken out with a cotton swab and placed on paper for observation, and there were fibrin clumps; it is confirmed by sales rep that the situation is true: the investigation situation is as follows: the laboratory operator is skilled in blood collection operations, inverted and mixed 5-6 times; centrifuge maintenance once a month; the mixing action is gentle, 180° up and down reverse; the blood standing time before centrifugation is 10-15 minutes; the blood sampling volume the blood volume of the sample is 3.5-4ml; the temperature at the time of blood sampling: 25° or less; use: constant temperature centrifuge, centrifugation time: 10 minutes.

Event Description

It was reported when using the bd vacutainer® sst blood collection tubes there was clogged/blocked instrumentation probes and oil gel globules.This event occurred 10 times.The following information was provided by the initial reporter: translated to english.The customer stated: on the morning of (b)(6), 2021, the customer complained that the instrument alarmed and blocked the needle when the yellow tube was on the machine; the alarm was taken out suspected oil droplets or gel balls were observed in the tube after the yellow tube; take it out with a cotton swab and place it on a paper for observation, it is sticky; the situation confirmed by the sales rep site is true: the investigation is as follows: 1: the general warehouse air conditioning in the hospital: room temperature below 25° ; laboratory air conditioner: below 25°; laboratory room temperature: below 25°; 2: laboratory use 2 thermostatic centrifuges: one of them: set temperature: 28°; rpm: 4000; xg: 2784; second station: set temperature 25°, rpm: 4000; xg: 3072; 3: clinical department operation: use an incubator to load blood collection tubes and transport to the laboratory window; 4: needle blockage and bleaching oil samples: 4 cases; customers are bd the quality of the product was questioned.The imported yellow tube was used in the past.Due to the cost of consumables, it was converted to suzhou yellow tube; the color and shape of the separating glue were different, and the quality difference of the separating glue was questioned, worried about affecting the normal use of the instrument, affecting work efficiency and inspection result.On 2021-3-16 received an update from the sales representative, and the description of the incident was updated as follows: the customer complained that when the yellow tube was on the machine, the instrument alarmed and blocked the needle; after taking out the alarmed yellow tube, it was observed that there were fibrin filaments/lumps in the tube; it was taken out with a cotton swab and placed on paper for observation, and there were fibrin clumps; it is confirmed by sales rep that the situation is true: the investigation situation is as follows: 1: the laboratory operator is skilled in blood collection operations, inverted and mixed 5-6 times; 2: centrifuge maintenance once a month; 3: the mixing action is gentle, 180° up and down reverse; 4: the blood standing time before centrifugation is 10-15 minutes; 5: the blood sampling volume the blood volume of the sample is 3.5-4ml; the temperature at the time of blood sampling: 25° or less; 6: use: constant temperature centrifuge, centrifugation time: 10 minutes.

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but photos were provided for investigation.The photos were reviewed and the indicated failure mode for oil gel globules and fibrin clots were observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to oil gel globules or fibrin clots were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure (oil gel globules and fibrin/fibrin clots).Because the defect was not evident in the testing of the retention lot samples.Evaluation of both retain and control samples tested were acceptable.All samples demonstrated clinically acceptable performance for all visual observations evaluated.Retention samples were tested for additive amount and all were within specification.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for oil gel globules and fibrin clots based on the photos provided.Retention sample testing was satisfactory.Bd was unable to determine root cause.

• Brand Name: BD VACUTAINER SST BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 11610445
• MDR Text Key: 251667091
• Report Number: 3006948883-2021-00358
• Device Sequence Number: 1
• Product Code: JKA
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 367406
• Device Lot Number: 0363361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1